chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash, blisters, (hives?) on 2 spots on left thigh with first shot.  This took couple of weeks to go away but still have marks left where blisters appeared. Second shot, waited 30 minutes due to first reaction per nurse.  Noticed I was itching around my face and next day my scalp was broke out in a rash all over and down the right side of my neck.  No major problem, just itches and still waiting for it to go completely away.
Product administration interrupted; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted).    No concomitant medications was provided. No treatment medications was provided. The patient was due for his second dose of the Primary Series Moderna vaccine and the Monovalent vaccine is not available. More than 36 days in between doses of the Moderna Primary Series.
STORAGE IN REFRIGERATOR ( 2°C -8°C ) UP TO 30 DAYS. VACCINE USED AFTER 10-16-2021.
Right eye redness + swelling occuring next day after shot. Pt did say she was pulling weeds the previous day.
tested positive for COVID; tested positive for COVID; Vaccine brand=Pfizer / BioNTech/Vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 041620A), in left arm, on 12Mar2021 as dose 2, single (Lot number: 001B21A), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 939905), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Abnormal heart" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Oct2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech/Vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative for 2 days; (unspecified date) Negative, notes: Tested negative for 2 days; (21Dec2022) Positive; (04Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient called her doctor and was sent in nirmatrelvir, ritonavir (PAXLOVID) prescription. Patient took it for five days (also reported as from 21Dec2022 to 27Dec2022). It worked great, she tested negative for 2 days and returned to work. On 04Jan2023, she tested positive again and was having bad symptoms again.
This spontaneous report was received from an administrator regarding a unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 28-JUN-2017, the patient received a dose of improperly stored dose of LIQUID PEDVAXHIB lot# M025194 and 22-MAR-2019 expiration date for prophylaxis (strength, frequency and route of administration were not reported). Data logger was reported. The temperature excursion was reported as 28°F for a time frame of 48 hours. No previous temperature excursion was reported. No adverse effects was reported. No product quality complain was present. This is one of several reported received from the same reporter.
Patient complaint two days after vaccine given of pain, redness and swelling on arm by area of vaccine. Tx: Toradol 30mg IM, OTC, Benadryl, OTC, Aleve or Advil.
Received menstrual cycle a week early, which is very unusual for me. I?ve gotten two more cycles a week early since then and they?ve lasted longer than usual.
Pt states on the evening of 8/8 developed a fever 101.5 and had shaking chills. On 8/9 developed redness, warmth, soreness and site felt "hardened" at vacine site @ 3" band. Left deltoid area. Pt stated he would follow up with his own doctor today.
Broke out in red rash all over chest, arms, back, neck.  Turned into having acne breakout as well.
Pt. rec'd 1 year IMM in office on 01-08-18. Returned for O.V. on 01-17-18 D/T rash (LT) arm which appeared 01-17-18. Afebrile; (LT) posterior arm with approximate 1" x 1.5" area of erythema; no induration, no warmth; non-tender to touch, no fluctuance. Not cellulitis. TX: Monitor. Ok for 5yr IMM.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 21-OCT-2012 10:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient reported to ED on 8 June, 2 days after vaccination,  complaining of painful, swollen, red area on L upper arm.  Records do not indicate exact site of immunization so cannot determine which vaccine was given in L upper arm.  Patient marked red area with a pen on 7 June and at time of ED visit, red area had expanded.  In the ED patient was given Benadryl and topical mupirocin.  Follow-up with patient on 9 June reveals symptoms are improving.
I was very sleepy after receiving the vaccination and took a nap around 7 PM. I woke up with a fever. I took some Advil around 8:30 PM. I started to feel nauseous and proceeded to vomit on and off until around 11:15 PM.
No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 05-MAR-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose detail were not reported) (lot # 1660942, expiration date 06-FEB-2020) orally for prophylaxis, which was reported as improperly stored (temperature below 2 degrees Celsius (1.28 degrees Celsius) multiple excursions, time frame was 2 hours and 30 minutes) (product storage error). There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. No PQC was reported.
Complained of light headedness, nausea, cold/clammy forehead at first, soon skin change to very hot and sweaty.  Came in with symptoms approximately 2 hours post injection. EMS called, taken to ER and received IV fluids, Benadryl and "some shots" per employee. Home from ER, with next day off to continue Benadryl and rest.
Patient develop large, red area that was raised, hot to the touch, tender and swollen the next day (parent sent us pictures). The reaction occurred on more than half of the patients arm/deltoid area with some redness extending to the medial part of the axilla/armpit. This lasted for "several days" per patient and parent report. No fever noted during this time. Patient preferred not take medication to alleviate symptoms.
vasovagal response - dizziness and nausea which lasted about one hour after injection - resolved with supine position and dry cereal
sore eye, upon exam, saw 5 cm bubble of fluid on top of right eye lid, causing swelling  and pain to right eye  After 3 days, the fluid drained during the night.Still tender to touch.
Fever 101.9, chills, extreme pain, redness, warmth, and swelling to the size of a soft ball.
I developed loss of taste and mild paralysis of the left side of my face about 8 hours after receiving the vaccine.  I went to urgent care.  Was diagnosed with Bell's Palsy.  I had Bell's Palsy about 20 years ago and went away after a couple weeks.  Haven't had any symptoms since.
Discharge Provider: MD  Primary Care Provider: DO   Admission Date: 11/2/2022 Discharge Date: 11/14/2022 COVID positive: 11/2/2022 Hospital Course: Patient is a 80 y.o. M with PMHx of COPD with severe emphysema, HTN who presented on 11/2 with respiratory failure 2/2 COPD exacerbation and COVID. Patient was having URI symptoms since 10/20 and having worsening difficulty breathing the prior two days. He was at baseline using 3L nightly but not using O2 during the day. In the ED, he was hypoxic requiring 4-5L NC.CXR demonstrated his severe emphysema and COVID was positive. He was given IV steroids, albuterol and azithromycin. In the hospital, patient continued with COPD treatment..Due to patient looking ill, CTA Thorax was performed 11/3 showing RLL airspace opacity concerning for infection. Rocephin was added at that time. Sputum culture grew Pseudomonas so antibiotics were switched to Levaquin. Patient slowly improved with cough regimen, inhalers in addition to finishing a 7 day course of antibiotics. He was eventually weaned to room air without activity. He was ambulated and shown to need 3L with activity. He was discharged with this increased oxygen requirement. He was also discharged with an extended steroid taper and follow up with his PCP.
Patient falsified the COVID questionnaire and did not disclose they had previous received both doses of Moderna.  Patient then received Pfizer under the impression it was their first dose from their screening with a healthcare professional.  No adverse reactions at this time.
pt had jerking movements of arms & legs beginning 1/2 hrs p/vax & cont for 1 1/2 hrs; also had low grade temp;
STARTED HAVING VERY BAD HEADACHE ABOUT 9 PM ON 4/14/2021, THEN STUFFY NOSE , SORENESS IN ARM, CHILLS AND STILL HAVE VERY BAD HEADACHE  AS SOON AS I WOKE UP AT 5 AM ON 4/15/2021 AN AND AS THE DAY GOS ON IM FEELING WORSE
As of now, experiencing flu-like bodyache, aching throughout the injected arm and limitation of arm movement.
Patient was administered with Menveo using another diluent; Patient was administered with Menveo using another diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered with Menveo using another diluent than the one supplied by Glaxo SmithKline, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The information regarding the patient was not reported.
A female 14 years and 11 months of age, was admitted to a local hospital because of ataxia and increasing lethargy. She had been treated since the age of 2 with carbamazepine for partial complex seizures. During the first 8 years of treatment, there were 23 measurements of serum carbamazepine had remained constant since she was 9 years of age. Because of persistent seizures at 13 years of age, gabapentin was added to her treatment program. The addition of gabapentin was associated with a decrease in seizure frequency of serum carbamazepine levels remained stable (range-8.2-12.4 ug/mL). During routine follow-up, 3 months before admission, seizures were well controlled. Weight was stable at 46.5kg and a serum carbamazepine level was 12.4. The child was continued on Tegretol XR 400mg in the AM and 600mg at night plus gabapentin 600mg 3 X daily. Thirteen days before hospitalization, the pt received the inactivated influenza vaccine Fluzone. The vaccine was well tolerated and no changes were made in the child's medication. On the day of admission, the child awoke, complained of nausea and subsequently vomited. She became dizzy and slept for 3 hours. On awakening, she was unsteady and had slurred speech. She became lethargic and poorly responsive. In the local ER, her serum carbamazepine level was 27.5 ug/mL and a urine drug screen was (+) for tricyclic antidepressants and cocaine. Tests of liver function were nml. The pt was intubated, transferred to an ICU and maintained on a ventilator for 19 hours. She received IV fluids and activated charcoal. Nine hours, after admission, her carbamazepine level was 24.5 ug/mL and levels continued to fall over the remainder of the hospitalization. A serum carbamazepine level, 4 days after admission was 9.1 ug/mL. At her last follow-up, 7 months later, the pt was seizure free and asymptomatic on her former dose of carbamazepine and gabapentin.
Pt states that shortly after administration her arm was sore and became progressively worse over following 3 weeks. Shot given 2/1/14.
After about 10 minutes he returned to the pharmacy stating his throat felt dry and scratchy and he felt a little dizzy. He was advised to sit down. He was given a bottle of water. The patient then purchased Benadryl and took 50mg. He continued to sit in the pharmacy and his symptoms were monitored. The patient stated that his symptoms were not worsening, but they were not residing either. The patient remained in the pharmacy for approximately 1 hour with no worsening of symptoms. He was advised not to drive after taking the Benadryl. He contacted a friend to meet him at the pharmacy. He then stated he was going to go home and continue to monitor his symptoms. He stated he will seek medical attention if his symptoms worsened. He was advised to contact his physician and inform him of the incident. The patient was advised not to get the second unless his doctor still recommended it, and if so, to receive the dose in a facility. The patient listed no allergies. The patient was asked if he had ever had a severe allergic reaction to anything in the past, and the patient responded he had not.
Hospitalization on 7/21/22 for breakthrough COVID-19. Chest weakness/pain, fatigue, hypotension, chills, cough and shortness of breath.
I began breaking out in hives about a week after Moderna booster. I have had hives for three days now. They appear and disappear throughout the day in different parts of my body: trunk area, palms of hands, feet, arms/shoulders, scalp, etc. I am taking benadryl which has hoped some but I am still covered in hives as I type this.
This is a spontaneous report from a contactable consumer. A 62-year-old female patient started to receive PREVNAR 13 (lot # and expiration date unknown, NCD: 00005 1971 02) via an unspecified route of administration at 1 DF, single on 27Oct2014. Medical history included asthma and diabetes mellitus from. Caller only mentioned asthma and diabetes as other medical conditions and declined to mention others, she says they are the only life threatening ones. She stated the asthma and diabetes keep her in the hospital a lot. The patient's concomitant medications were not reported: caller declined to provide other medications, they were too many. The patient experienced sleepy on 27Oct2014, burned a little going in on 27Oct2014, sore right arm on 28Nov2014, it made her mind slow down on an unspecified date in 2014. The patient recovered from Sleepy and Burned a little going in on 27Oct2014, and from sore right arm in 2014. Therapeutic measures were taken as a result of sore right arm. Course of events: Caller mentioned that when she received PREVNAR 13 vaccine on 27Oct2014 that it burned a little going in, she got a little sleepy for about 15 minutes after receiving the vaccine and the next day her right arm where she received the vaccine was sore for a day and a half. Caller also mentioned that it made her mind slow down which she liked. She also stated that the symptoms wore off before she left the office. She told the nurse she was back to normal. She said her arm was a little sore. She took some ibuprofen when she got home. The next morning it was still a little sore, not horrible. Caller said she is no longer experiencing any of those symptoms anymore, the symptoms are normal and her experience was not bad at all. Caller gave permission for Pfizer to contact her physician for further questions if needed.
Information has been received from a physician concerning a 36 month old patient who on 18-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot #, expire date and route not reported). Physician stated that on 19-FEB-2011 after receiving VARIVAX (Merck), the patient experienced fever and on 20-FEB-2011 the patient experienced "white blisters with red centers". The patient sought medical attention by phone call. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Patient complained of severe dizziness a few minutes after COVID vaccine. We had patient lie down on her back with her feet elevated. She had paleness,  coldness of extremities and sweating.  We maintain an open airway and apply cold compresses. Patient symptoms improved after 30 minutes,
Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report was received from Consumer and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-JUL-2023, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1968385, expiration date: 22-MAY-2024, administered orally for prophylaxis (strength was not provided).   ; Sender's Comments:  US-009507513-2307USA009885:
After MMR vaccine was admitted patient had constant low grade fever, constant diarrhea. Patient stopped talking, developed behavioral problem and autism.
On 12/30/2020, patient received Pediarix and Flu vaccines in her LLE and Prevnar in her RLE. In the LLE patient developed what appears to be an abscess that developed shortly after vaccination. In the left thigh has grown slightly and draining what appears to be non odorous yellow discharge.  Wound culture was obtained and sent to the lab.  In the RLE, patient developed a similar but smaller mass. Sit e is red but there is no drainage. Patient has no fever, no chills, changes in appetite or behavior. She is slightly uncomfortable when either lesion is  palpated, left greater than right, despite persistent warm compresses, the left thigh continues to have purulent drainage.
Inadverently given Bivalent instead of Monovlaent as 2nd dose in primary series.
This case was reported by a nurse and described the occurrence of chest pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 12th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In November 2018, the patient experienced fatigue, skin warm, pain, headache, malaise and shivering. On 16th November 2018, the patient experienced chest pain, dizziness and ringing in ears. In November 2018, the outcome of the fatigue, headache, malaise, shivering and dizziness were recovered/resolved. On 16th November 2018, the outcome of the chest pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, skin warm, pain and ringing in ears were unknown. It was unknown if the reporter considered the chest pain, fatigue, injection site erythema, injection site swelling, skin warm, pain, headache, malaise, shivering, dizziness and ringing in ears to be related to SHINGRIX. Additional details were received as follows: This case was reported by nurse who herself was the patient. After vaccination with SHINGRIX, the patient had many of the common and uncommon side effects. The patient presented with vaccination site redness and swelling which happened within 12 hours after vaccination with SHINGRIX. Within 24 hours after vaccination, a large red streak, measured approximately 3 by 1 inch, developed about 3 inches below the injection site. It was hot, swollen red and painful. The patient presented with headache (HA), malaise, shivering, fatigue which lasted for 36 hours. Four days after vaccination with SHINGRIX, the patient developed pain in chest that lasted for approximately 25 minutes and felt like she was going to faint, dizziness and ringing in her ears. The patient never felt this events before. The patient was taken by ambulance to the emergency department (ED). In ED, the patient had done 2 EKGs (electrocardiogram) and  2 troponins test which showed results stable normal vital signs. Everything was normal and the patient did not have a heart attack. Two days later, the patient had a 100 percent normal stress test. The patient had not told to her coworkers about her chest pain or feelings of faint. The patient asked if GlaxoSmithKline (GSK) had any reports of chest pain or fainting symptoms after receiving SHINGRIX vaccine and if it was recommended to receive the follow up of SHINGRIX in 2 months. This case was linked with case US2018GSK219275 (master case), reported by the same reporter.