chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from Registered Nurse regarding 12 month old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
accidently administered PROQUAD and VARIVAX to a 12 month old patient yesterday, 8/10/22, instead of VARIVAX and MMR-II therefore the patient received an extra dose of Varicella; accidently administered PROQUAD and VARIVAX to a 12 month old patient yesterday, 8/10/22, instead of VARIVAX and MMR-II therefore the patient received an extra dose of Varicella; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unspecified gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 10-AUG-2022, the patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (PROQUAD) (rHA), 0.5 milliliter, lot #U029150, expiration date: 16-MAR-2023 (anatomical location was not provided) administered subcutaneously as prophylaxis, and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter, lot #U027326, expiration date: 02-SEP-2023 (anatomical location was not provided) administered subcutaneously as prophylaxis, instead of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant (M-M-R II), receiving and extra dose of varicella vaccine (accidental overdose and wrong product administered).  The reporter requested information about how to proceed with the patient and if there were any issues to be concerned about.
Chicken Pox blister appeared on my face.  I got a fever Friday night 11/5/10. Blisters continued to appear on my body clear through 11/9/10.
Given 1/27 at 11:30 am. Reports pain - started 1/28 and left arm became red (circle), raised and warm to touch - continues to be red, raised and warm on 2/1.
On the morning of the 24th I noticed a large, circular, red, raised lump on the head of my humerus above the injection site. As the day went on, my neck became sore, and I could feel swollen lymph nodes. No fever, no sore throat, no cough.
8:30 PM began to feel very tired and a little under the weather. Throughout the night I kept waking from sleep with discomfort/tightness in the chest. Got up about 2:00 am to get some air. Drank some water and tried to walk down the hall when I got lightheaded. Went back to my bed and sat down. Still felt lightheaded and I tried to breathe slowly recover but I passed out for maybe about 5 minutes. Time enough for our neighbor (a nurse) from downstairs to come up to help my wife who called out when she heard the thump of me hitting the floor, as I lay there pale and unresponsive. When I came too I could not move as it instantly made me nauseous and lightheaded. The paramedics arrived and helped me up into a wheelchair at which time I began dry heaving 3 times and then vomiting. They took me to the hospital for monitoring, where I was released at 5:30 am.
pain at site; body aches; low grade fever; headache; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced injection site pain, general body pain, fever and headache. On an unknown date, the outcome of the injection site pain, general body pain, fever and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, general body pain, fever and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced injection site pain, body aches, low grade fever and headache. The duration was 36 hours. All adverse event resolved.
No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T018892 with an expiration date on 02-JUN-2022) for prophylaxis (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursión of above 9°C Celsius degrees (18.9°C) for  18 hours, 0 minutes and 0 seconds (product storage error).    No previous temperatura excursions were reported.  No additional adverse effect were reported.  This is one of the five reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003819:Original Case : 2108USA003819 US-009507513-2108USA003903:Original Case : 2108USA003819 US-009507513-2108USA003905:Original Case : 2108USA003819 US-009507513-2108USA003902:Original Case : 2108USA003819
Pt was incorrectly given the booster. This pt was not suppose to have received the booster.
Complaint of cough, elevated temperature, sore/scratchy throat, and runny nose/congestion,
Vaccine administered on 9/5/08. Patient was soon at emergency room at MC on 9/12/08 for febrile seizure (T - 104.6)
This spontaneous report as received from a health worker (medical assistant) refers to 19 years old female patient. The patient's medical history included mononucleosis. On 08-MAY-2012, the patient was vaccinated with dose 2 GARDASIL. Lot number and the dosage regimen was unspecified. No concomitant medications were reported. Approximately in August or September 2012 (reported as last week), the patient experienced mononucleosis. The patient sought medical attention and was seen in the office. Last week, the patient was treated with an unspecified antibiotic for the same, but was now discontinued. The outcome of mononucleosis was reported as recovered/resolved and the patient was fine. Additional information is not expected.
rt arm was not swollen on 7APR or 8APR but on 9APR93 was red & swollen huge @ bedtime pt was taken to ER; MD also noted lymph glands in neck were swollen;
Records indicate patient received typhoid vaccine on 12Sep2011 and again on 14Oct2011. Uncertain if this was administrative error or acutal event.
Patient received 3rd dose of moderna COVID vaccine no adverse reactions at time or thereafter from Patient. This submission is to inform of 3rd dose.
Mother brought child to Doctor to get Varicella #2.  Instead Doctor gave her Hep A #2. She just received her Hep A #2 three weeks earlier from Dr. Then he wanted to give client her 2nd Varicella and her mother woudn't allow it. Mother stated client stated she had more pain in Left arm due to 3rd Hep !.  Told mother to give Ibruprofen as needed, maybe use a cool compress on area and move the arm around.
The morning after the injection I woke with a migraine, severe pain in the injection site, extreme body/muscular pain, fever, nausea and fatigue. These symptoms lasted about 3 and a half days before easing off. By the end of the 4th day I was finally able to function almost normally.
pregnant; pain at injection site left arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (pain at injection site left arm) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date, Miscarriage on 09-May-2020 and Pregnancy (live full term birth) on 07-Mar-2019. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Jul-2020 and the estimated date of delivery was 11-Apr-2021. On 28-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (pain at injection site left arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-eighth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved and VACCINATION SITE PAIN (pain at injection site left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events were not provided On FEB 2020, Patient had ultrasound
not feeling really well; injection site is very sore; Armpit became very sore; Fever; Joint pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever) and ARTHRALGIA (Joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient history Information was provided.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], FOLIC ACID and FLUOXETINE for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided.   Reporter did not allow further contact
Pt. presented to the office to receive the required 7th grade entry vaccine MCV4.  After receiving the IM vaccine, she complained of feeling lightheaded, became pale and sweaty but never lost consciousness.  Mother was present.  PHN raised the client's legs while explaining to her why this was done.  Cool clothes were applied to the back of the neck as well as the forehead.  Mother also assisted with keeping the child's legs elevated.  She continued to talk, was given a Ginger Ale with improvement.  She remained in the clinic for approximately 45 minutes before ambulating out of the office with mother by her side, and without problem.
Hives, facial swelling, nausea and fatigue OTC benedryl, zyrtec and pepcd, as well as tylenol for headache
woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; hands were shaking; she felt as if she was going to faint; This is a spontaneous report from a contactable consumer (patient's husband).   A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Feb2021 12:30 for Covid-19 immunisation, being a caregiver.  The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine for immunization and had side effects. On 06Feb2021 she woke up feeling unwell a few hours before reporting. Reporter and patient went for a 4 mile walk and she felt sluggish during the walk and her heart was racing, hands were shaking and she felt as if she was going to faint. When they arrived back home the reporter checked her heart rate and it was not that high and her symptoms were subsiding. The reporter would like to know if his wife should go to the ER. A few years before the patient had side effects from the flu vaccine so he was expecting her to have a reaction to the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included heart rate: it was not that high on 06Feb2021.  The outcome of events was recovering. The reporter assessed the events as not serious.  Information on the lot/batch number has been requested.
hives started 24 hr after inj, first on face and scalp, subsided by 72 hr. March 30, pt on vacation at the beach, "rash" on trunk, attributed to sunburn. Relieved with diphenhydramine and gone ~12 hr. April 4, "rash" reappeared trunk-back/chest, went to urgent care, referral to dermatology. April 7 seen by dermatology, cetirizine bid, triamcinolone ointment prn,benadryl at bedtime prn if needed, diagnosed as hives. Continued with "flares". Nothing specifically identified as the cause? Mom with hives as well(reported in separate form). Only common denominator, Moderna vaccine. No hives for pt's father(vaccinated with Pfizer) or sister(15 y/o, no vaccine yet). No changes to home environment. No improvement in s/s. Seen by dermatology for f/u April 17, increase to cetirizine q 6 hours w/ one month f/u and potential for prednisone taper if needed. Now, May 8, hives are much improved, still on cetirizine q 6 hours. No prednisone used yet. Follow up with dermatology on May 17. Of note, when dose of cetirizine is delayed... symptoms come back.
Chills, body aches, fevers, cough, sore throat, fatigue started the evening of my vaccination. Fever up to 100.5 today.  At home treatment with Tylenol, rest & po fluids.
Approximately 10 minutes after receiving the vaccination, the patient developed facial flushing, blotching of the skin, and complained of throat pain/tightness with associated shortness of breath. Patient received epinehprine 0.3 mg auto-injector at the clinic where the vaccine was received and was then transferred for further observation. No further interventions were needed and the patient was discharged home same day.
Arm soreness at injection site, body aches, headaches. All occurred approximately 12:00pm the day after the injection and lasted 8 hours.
At injection site the site became hot, red, swollen, ichy about the size of my hand I took Benedryl for a couple of days and the hot, swelling and ichy subsided but still have a red spot about the size of my hand still remains
Headache, Fever, CHILLS, BODY ACHES, NAUSEA, FATIGUE;  SORENESS PAIN AND ITCHING AT INJECTION SITE   Narrative:  LUMP ON ARM
Pt recvd MMR vax on 12NOV85; Exp mumps & a fever of 102 on 04SEP90;
she forgets her own address; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 18Jan2021 17:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she was fine and wanted to inform that she had her Covid vaccine shot on 18Jan2021 at 17:00. She has not been sick and does not have fever. She was now waiting on the date for the second dose. She then mentioned that she forgets her own address on Jan2021. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Parent calls - reports vomiting started 2 hrs after vaccines, repeatedly, no fever, took child to urgent care. Given anti-emetic. No one else in family got sick, no further GI symptoms over weekend. No hives, no respiratory symptoms.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.; No adverse event; Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date.).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
"Pfizer-BioNTech COVID-19 Vaccine EUA Day two injection site very sore.  Day three I woke up to pain in my left arm pit area, upon inspection noticed a baseball sized swelling in arm pit.
got Covid positive after getting the 1st dose; got Covid positive after getting the 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported similar events for 2 patients (husband and herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 15Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her 1st dose of vaccine BNT162B2 on 15Feb2021 and was tested COVID-19 positive on an unspecified date. The patient was scheduled for second dose of vaccine BNT162B2 on 15Mar2021. Outcome of events was unknown.  Information on lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268440 Differente patient, same drug and AE.
p/vax pt exp red circle surrounding dime size, hard nodule w/some bruising, zero induration
light headed Pt. in tent is felt lightheaded at 4:40pm after vaccine at observation site paramedics assessed pt. took vitals which were stable.  Monitored until symptoms subsided.  At 5:15pm pt. was released to go home.
Allergic reaction all over the body which started 56 hours after the 2nd vaccine shot. Legs, arms, back and torso covered in hives
Jynneos use for MonkeyPox for pediatric use under Emergency Use Authorization (EUA). This occurred while treating a pediatric patient under the EUA along with their parent. When the caps were removed for use, on one vial the cap was difficult to come off and created a very sharp edge where the nurse could have cut themselves (on the right in photo). The other vial (on the left in photo), the metal cap came completely off and then when the nurse went to withdraw from the stopper, it just "popped" out. This potentially affects the integrity of the products, however, both patients received full dose and experienced no harm. It was confirmed other similar instances have occurred in the same institution.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016 (reported as "between 18-JUL-2016 and 04-AUG-2016"), the patients were vaccinated with improperly stored doses of PROQUAD lot # M004894 with expiration date: 27-JUL-2017 and lot # L007228 with expiration date: 03-SEP-2016 (dose, therapy type and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of -10.8 degrees Celsius for 35 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
patient says she was fine after the injection but later on that night fainted. she went to the emergency room and says the doctor ran a bunch of tests and did scan of her brain with no conclusive results as to what caused the syncope.  patient was then traveling for 2 weeks and just returned to contact pharmacy. still does not feel like "herself" but does report also being jet lag. it was recommended that she follow up with her primary doctor
Patient tested positive for COVID 4/26/21. Completed COVID vaccine series 1/12/21.