chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hive like apperance/circumference is 3 and a quarter inches; itchy; redness; swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (hive like apperance/circumference is 3 and a quarter inches), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness) and SWELLING (swelling) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement in 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), RAMIPRIL, GABAPENTIN, LEVOTHYROXINE, VITAMIN D NOS and BIFIDOBACTERIUM INFANTIS (ALIGN) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (hive like apperance/circumference is 3 and a quarter inches), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness) and SWELLING (swelling). At the time of the report, VACCINATION SITE URTICARIA (hive like apperance/circumference is 3 and a quarter inches), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness) and SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified allergy shots taken once a week.   Treatment included loratadine and topical diphenhydramine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt states that he received Moderna Vaccine # 1 (lot 025J202A) 12/30/2020 through the Regional Health Care Center and did well following that shot.  Received Moderna vaccine # 2 shot through the same setting on 1/27/2021 @ 1400.  Felt flush and fatigued through the early morning, took his temp this a.m. at 0930 and reported temp ranging to 100.4 F  Pt states that his usual baseline body temp is 97.  Pt states aside from a bit of fatigue he is otherwise without symptoms.  He works part time as a mental health counselor.  Pt was screened for COVID 19 and as well for influenza, those test results are pending at the time of this submission.  I did discuss with the patient that a bit of fever following receiving vaccines is not an uncommon side effect.  I did also encourage the patient to participate in the V-Safe registry program.
Patient received second dose of Moderna Covid 19 vaccine. Patient  was age 16 ;therefore, not in approved age group for Moderna vaccine. Father was contacted today and reported child has had "no problems" following vaccine administration.
no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning a 1-year-old female of patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 30-AUG-2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, dose, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023). The administered dose of the vaccine was stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported.  This is one of 5 reports received from the same reporter. ; Sender's Comments:  009507513-2210USA004932: 009507513-2210USA009380: 009507513-2210USA009378: 009507513-2210USA009379:
Pt recvd measles vax JAN89 & had mild visual loss w/ acuity being 20/30 in both eyes uncorrected; pt had pupils scarred & was unable to dilate in a dark room; the iritis has been persistent for yrs; MD felt poss idiopathic pars planitis;
IM given 9/21/10 left deltoid. 9/22 c/o aches, sore arm. 9/23 large, red, warm and swollen area on L upper arm. Diagnosed in ER with cellulitis, given IV ANCEF and antibiotics p.o.
Patient's mother called and stated that the patient was getting a rash over his body and down the arm he received the shot. No problems breathing.
POST VACCINATION PT. REPORTS NAUSEA AND NUMBNESS AND TINGLING TO BILATERAL HANDS. PT. REPORTS HX. ANXIETY AND PANIC ATTACKS, ALSO VERBALIZED BECOMMING ANXIOUS AS SHE WAS UNABLE TO BE VACCINATED WITH HER DAUGHTER. VS OBTAINED. INSTRUCTED ON BREATHING EXERCISES, OFFERED LITE SNACK AND WATER. NEURO INTACT. PT. REPORTS ALL SYMPTOMS RESOLVED.  PT. AMBUALTED TO EXIT WITH STAFF AND DAUGHTER.  VS AS FOLLOWS: 1718 BP LYING 151/91, HR 90, RESP 18, O2 SATS 98% 1724 BP SITTING 155/96, HR 92, RESP 18, ,O2 SATS 95% 1738 BP STANDING 150/81, HR 97, RESP 18, O2 SATS 97%
Adverse events reported to V-Safe monitoring. Started day following vaccine, headache, fatigue, generalized itchiness requiring antihistamine. Progressed  by day three to chest tightness and pain, stiff neck, rash on forearm. Went to ER day four due to feeling chest tightness and difficulty catching breath during a walk. The chest tightness and pain felt very similar to two other events I have had in the past, one in 2019, due to reactivation of herpes zoster virus and post herpetic pain after trauma of a fall on the deck of a ship in rough seas, and in 2016 the first time I was diagnosed with shingles in the hospital, when I was evaluated for chest pain. On 7/1 Legacy ER transferred me to facility for admission and further evaluation.
Bones ached - Skin very tender on entire body, tired, no appetite, sight of shot red, swollen + sore. Finally got warm 9-28 about 6 pm - shot sight sore + itchy until Monday 10-1
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-MAY-2012, patient received improperly stored VARIVAX dose 1, from batch/lot # 671861/1907AA ( expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one the several reports received from the same reporter. Additional information has been requested.
administered after it had been exposed to freezing temperatures; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Herpes zoster (Shingrix) (batch number N3S45, expiry date 27th May 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.       Additional Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: The office manager repored a patient was administered Shingrix after it had been exposed to freezing temperatures. The reporter consented to follow up but did not specify phone or postal, address above was office address. Additional Supportive Information: As the patient was administered Shingrix vaccine which was exposed to freezing temperatures, which led to incorrect storage of drug.
6/1/22 pt sent to ED from Cancer Center after a syncopal episode and hitting head; SOB; signs of bilateral pneumonia respiratory failure and positive for COVID; O2 supplement; ABX, remdesivir, steroids; developed recurrent bleeding during hospitalization related to esophageal CA; pt's respiratory status worsened; recurrent bleeding; pt transitioned to comfort care and expired in the hospital
My wife tested positive a week before. I then started with allergy symptoms and tested for COVID-19. Cough, runny nose, no fever. They never got terrible and only lasted a few days. I did not take any antiviral medication.
pt recvd vax; irritability for more than 4 hrs, inconsolable;
Need my physician to provide the specific manufacturer/batch. Within hours of the vaccine, I felt irritable, feverish, tired for two days. I had the vaccine Friday the 14th. By Monday the 17th, I started bleeding, I passed a blood clot the size of a baseball. I went to the hospital and they believed I had a placental abruption. After monitoring me for two days, and the baby's heart rate continuing to drop, I had to have an emergency c section 5 weeks early.
Chills and fever started about 12 hours after shot, also stomach upset; Fever, chills, and upset stomach lasted for about 24 hours. Pain in arm and redness started about 2 hours after shot. It lasted about 3 days. I took acetaminophen for chills and fever.
No additional AE details provided; Improperly stored PROQUAD administered vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 26-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T029103, expiration date 23-FEB-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The storage temperatures of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was 9.6 Celsius degrees for 80 minutes. There was no previous temperature excursion. No additional adverse event details provided (no adverse event). No product quality complaint (PQC) was reported.
Swollen itchy eyes, hives to back of neck. These symptoms went away after 24 hours. Friday 11/4/16 5:30 PM-Eyes itchy, right eye pain, bottom lip swollen, hives on entire back and abdomen.
I felt achy and tired the evening after the vaccine yesterday (12/17).  This morning I felt very tired, had muscle pain, a headache, shivering, and nausea.  Very similar to having the flu.  I ended up not going in to work that day. I understand symptoms can last a couple of days.
Tingling in feet, Tachycardia, hypertension, itching, hot flashes, flushing
pt reported redness, warmth and swelling to injection site the next day. symptoms lasted about 5 days
Case number PHEH2013US013240, is an initial spontaneous report received from a nurse on 14 Jun 2013 and a follow up report from the nurse received on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in the left deltoid on 12 Jun 2013. Reporter stated that, an un-reconstituted MENVEO reached-1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up report from the nurse received on 09 Jul 2013: The therapy dates of MENVEO vaccine and site of vaccination were updated.
22apr96 pt recv vax from a nurse who did not review  medical hx w/ pt.  He recv a cadaver kidney in 1990 & everything was working well until the vax.  Post vax pt exp acute rejection of kidney & then chronic rejection of the kidney.
ache arm; mild tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (ache arm) and FATIGUE (mild tiredness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (ache arm) and FATIGUE (mild tiredness). At the time of the report, PAIN IN EXTREMITY (ache arm) and FATIGUE (mild tiredness) had resolved.            Patient recovered after half day. No treatment medications were provided.  No concomitant medications were provided.
Information was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an expired dose of VAQTA, lot # N005796 for prophylaxis (expired vaccine used) (dosage schedule and route of administration were not reported). No adverse effects were reported.
Pfizer vaccine was administered outside of source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------ I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 8/22/2022 RECTAL BLEEDING I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 8/22/2022 HEMATURIA I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 8/22/2022 PROSTATE CANCER I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 8/22/2022 ATRIAL FIBRILLATION, PAROXYSMAL I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 8/22/2022 ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE WO ANGINA
had a bad reaction; This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a bad reaction. The follow up consent was not granted
Information has been received from a licensed practical nurse concerning a patient who was vaccinated with Rotateq first dose po. The patient was administered the first dose of Rotateq at 18 weeks of age. The nurse reported that there was no adverse experience related to this event. Additional information is expected.
been in contact with someone who is Covid-19 positive; Chest tightness; Low grade fever; Vomiting; Cough; has been sick since getting the vaccine; tired and fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 11Jan2021 at a single dose for front line worker (covid-19 immunization). Medical history included ongoing HIV since 2015. There were no concomitant medications. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for front line worker (covid-19 immunization). The patient reported that he received his second dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday (11Jan2021) between 8:00 am and 8:30 am, and since then he has been sick and has been experiencing some side effects. He mentioned that he has been in contact with someone who is Covid-19 positive on an unspecified date. He works at the front desk registration in a hospital. He has been tired and fatigued, has had a low-grade fever, vomiting, headache, cough and chest tightness. He added that on Monday evening (11Jan2021), he became tired and fatigued. He had an on and off fever on Tuesday (12Jan2021). He started vomiting while coughing on 12Jan2021. He went to the doctor last night (13Jan2021) and he said he got tested for Covid-19 on 13Jan2021, but the results came out negative. The physician said that it would. However, his physician said that it was too early to tell if he has been infected since he has just been exposed last Monday. Normally, they like to have a 5 day turn around for a true reading. He said his physician told him he just needed to quarantine. He mentioned that his chest feels tight when he coughs on 13Jan2021. When he had to take deep breaths while the doctor was listening to him breath his chest was tight. He had blood work drawn at the doctor's office, but he does not have any results to provide. The patient wanted to know what he needs to do about this. He was inquiring if there any recommendations. He is probably negative because he is symptomatic. His employer said it may be a reaction from the shot. The outcome of the events sickness and exposure to COVID-19 were unknown, as for the event vomiting was recovered on 12Jan2021 while the outcome of the other events was not recovered.    The following information on the batch/lot number has been requested.
Developmental speech apraxia with sensory integration/fine motor control issues. Occupational therapy until 2/26/02 speech therapy ongoing. Mild autism.
Patient developed a red rash on 8/2, 7 days after receiving her first Moderna vaccine. She said that her arm was sore a couple of days after she got the vaccine, then it became itchy (and she says she scratched at the injection site), and then on 8/2, it became red, warm to the touch, and tender.
This spontaneous report as received from a registered nurse refers to an 11 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 07-JAN-2016 at 11:12, the patient was vaccinated with a dose of improperly stored GARDASIL intramuscularly in the left deltoid, lot number L019297 (strength, dose, dose number and expiration date were not reported). On an unknown date in approximately 2016, the patient experienced tonsillar enlargement, temper tantrums and bilateral near sightedness. The outcome of tonsillar enlargement, temper tantrums and bilateral near sightedness was not reported. The relatedness between these events and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt became very lethargic, confused, unable to hold herself up, BP dropped to 100/50 and HR to 48, spit up several times. First checked blood pressure and then decided to call EMT. EMT arrived and she became more awake and alert. Pt and son decided to go to urgent care to be seen.
Omicron BA.1/BA.2 coinfection; Omicron BA.1/BA.2 coinfection; This is a literature report for the following literature source(s).  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic lymphocytic leukemia/small cell lymphocytic leukemia" (unspecified if ongoing); "chronic lymphocytic leukemia/small cell lymphocytic leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Chemotherapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Omicron BA.1/BA.2 coinfection". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: 123, notes: (Approx 90 days post vaccination); Multiple fragment analysis: COVID-19 cases caused by coinfection with, notes: different SARS-CoV-2 variants (Delta/Omicron BA.1 and Omicron BA.1/BA.2); SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after 3 doses of BNT162b2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202201307875 Same article, drug, event and different patient;
gets an enlarged lymph node; This is a spontaneous report from a contactable physician (patient) received via a Pfizer-sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reiceved the Pfizer COVID vaccine a week ago. She typically gets an enlarged lymph node after receiving the influenza vaccine and had the same reaction to the COVID vaccine on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient reports a 'lupus topical reaction all over her body'-patient contacted her provider regarding whether she should get the 2nd moderna vaccination
Patient felt pain immediately when the shot was given. This pain radiated down her arm to her fingertips. Immediately afterwards, her arm was really sore and continued to be sore to present date. Patient states it is mostly her shoulder that is sore at night and when her arm is above her head. Today, she feels the pain is much better than when she first got the shot and can see improvements in her functionality/range of motion daily. She denies any other symptoms such as fever or chills. She did not seek the care of her physician after the shot and does not intend to seek medical care for this stating "it realy has gotten a lot better since."
9 x 13 cm redness and induration on (L) arm moving arm well but pain when he elevates arm.
Neuropathy type tingling, burning in back, arms, legs.  In the beginning the feeling was almost always (so much it kept me up at night) but at this time (august) seems to be improving.   I haven?t had any injuries or accidents.   I initially thought it may be my thyroid medications.  So I contacted my doc and we ran labs Which came back fine.   They are keeping me suppressed due to thyroid cancer history.  TSH 0.97 Free T4. 1.20.  I am an RN.   I don?t have diabetes, I?m relatively healthy. I can?t think of anything else it could be.  So just trying to help with data in case anyone else is experiencing this after the vaccine.
Nosebleed, Headache, Malaise, Temperature of 100.7.