chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 22 year old female who on 30-MAR-2010 was vaccinated on left deltoid with the second 0.5 ml dose of GARDASIL (lot# 663454/0672Y). Concomitant therapy included PROMETRIUM. On 31-MAR-2010 the patient experienced rash, face swollen and hot. The patient didn't experience any AE on first dose. The patient sought unspecified medical attention. At the time of report the outcome was unknown. Follow up information was received from a Registered Nurse concerning the 22 year old female with no medical history or concurrent conditions who on 30-MAR-2010 at 9:00 AM (also reported as 10:00 AM) was vaccinated IM on left deltoid with the second 0.5 ml dose of GARDASIL (lot# 663453/0672Y). Concomitant therapy included PROMETRIUM 200 mg. There was no illness at the time of vaccination and adverse event following prior vaccination. It was reported that the patient woke up in the morning of 31-MAR-2010 at 7:30 AM (also reported as 7:00 AM) with rash, swollen face and felt "hot". She was having her normal breakfast food, nothing new and denied any new soaps, detergents, or perfumes. The patient was instructed to take BENADRYL and to go to emergency room if she had difficulty in breathing/swelling. The patient stated that she felt fine except swollen and hot. At 2:00 PM on that day the patient stated that symptoms were improving. She still had hives on back of neck and shoulders but no more face swelling or body rash (It was also reported that at 3:00 PM the patient's rash continued, swelling of face recovered and hives on back of neck and shoulders continued). Additional information has been requested.
Hospitalized (1.10.22); COVID-19 positive (1.10.22);  Fully vaccinated (no booster) Admission Date: 1/10/2022 Discharge Date: 1/12/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient is a 78 y.o. male who presented with chief complaint of shortness of breath, sinus congestion and fatigue.  Patient reports that his whole family got exposed over new year and developed symptoms for COVID 19. He started having symptoms on 01/04 which started as a head cold and progressed to having dyspnea.  Patient denies any fever, nausea, vomiting, diarrhea or chills.  Patient's wife, son and daughter-in-law also tested positive for COVID-19. On admission to the emergency department was found to be hypoxic requiring 2 L of oxygen to keep sats above 90%.  Chest x-ray showed left-sided pneumonia.  Patient's labs within normal limit except for slightly elevated CRP.  Patient received 1 dose of Decadron in the emergency department.  His was admitted for management of COVID-19 pneumonia. Patient was started on remdesivir and dexamethasone.  Albuterol p.r.n. and Mucinex was ordered.  Patient reported improvement in his symptoms the next day.  He was able to be weaned off of supplemental oxygen to room air.  Patient was evaluated for home oxygen requirement and was found to be stable on room air at rest and with ambulation.  He was discharged home in stable condition
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 11-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (strength was unknown) (lot# M034856 and expiration date 27-JUL-2018) subcutaneously for prophylaxis (Incorrect product storage). The MERCK STERILE DILUENT was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017; 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 07-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Swelling, skin hard to the touch. Hot to touch. Redness increasing-  currently red ~7" long around arm and 3" high down arm.
Pt woke up at night with extreme itching on both legs and arms. Pt took Benadryl with some relief.  Sxs came back next morning.
I do not know which vaccine brand she received - only  that it was RSV and Hep B vaccine given by her primary doctor.   She has a diffuse itchy painful rash consistent with allergic reaction, not resolved after 5 days while being on Prednisone.   rash started a couple of hours after receiving the vaccinations.
Itchy throat, headache,flu like symptoms, pain and weakness on vaccination site(RightArm)
It was reported that a female pt received a Menomune A/C/Y/W-135 vaccination on 8/1/00. Reportedly, within 24 hours, the pt developed a fever of 102F, headaches and neck pain. Further information requested. *F/UP report on 3/4/03: It was reported per the PT that the Sx's resolved after 1-2 days and the PT recovered. This case is closed.*
Beginning 3p  on 2/1:  nausea, pain throughout entire left arm  By 10p on 2/1: nausea, pain throughout entire left arm, painful lymph nodes under left arm, dizziness, nausea, joint pain, muscle aches, hot flashes, chills, loss of appetite/vomiting, headache, fatigue  Symptoms persisted at an intense level for approximately 3 days
Onset of weight gain, lower extremity swelling 2/24/2021. Labs completed 3/1/2021, diagnosed with mild rhabdomyolysis on 3/4/2021 given proteinuria, myoglobinuria, elevated CK - unknown etiology/trigger for rhabdo.
Fever 99.8 -100.3  for  12 hours - took tylenol  Body Aches for 48 hours - tylenol  Headaches for 36 hours Nausea for 4 hours Extreme exhaustion for 36 hours slept 20 hours Redness at injection site and down arm 48 hours later
Pneumonia of both lungs due to infectious organism. She was admitted inpatient, empirically treated with IV antibiotics for pneumonia, respiratory panel returned positive for parainfluenza.  Repeat echocardiogram was done, results as above. She was weaned off supplemental oxygen. Discharged home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Lot # 053E21A was administered outside the 30-day Use by Date.  A case was opened with Moderna ID Case ID.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
dizziness, light headed/blurred vision, headache/ body/aches,  increased heart rate, nauses, temp/clamy
Record of events were obtained from who is patient daughter as follows: Initial reactions occurred on 11/8/21 whereas patient developed blistering of left hand inbetween fingers and palms. The symptoms spread to right hand as well but not as severe. Patient received evaluation from a provider at This is not patient primary provider. She was not able to be seen that day by PCP. She was evaluated and prescribed cortisone cream "high dose" and was advised possible medication reaction.  She was seen by PCP via a telehealth appt on 11/15 at. Reports the symptoms were better and almost resolved at the time of telehealth visit. She was prescribed triamcinolone cream at this visit. I spoke with patient on 11/15 and with her daughter on 11/17/21 and she reports that symptoms are almost resolved at this time. Patient is to follow up later with PCP.
1 wk p/vax taken to ER w/high fever (106.3), lethargic, vomiting & sz; rash on 14OCt93; treated w/APAP & pediaprophin & sent home;
08/04/14 Pt had vaccines in office in afternoon. 08/05/14 Patient woke and stated her eyes felt very itchy. She also felt SOB. She had to leave for work. She progressively got worse took CLAIRITIN with no relief. SOB became progressively worse Rt arm where ADACEL was placed was hot to touch and she denied throat closing. Was given in office Albuterol and felt improved. SOB was dissipating. Was D/C'd with albuterol MEDROL Pak. Called next day Pt states felt 90% better.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL, 0.5 ml, intramuscular. Other suspect therapies included PEDVAXHIB. On an unknown date the nurse reported that the patients were administered with improperly stored GARDASIL and PEDVAXHIB. No adverse events were reported. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 5 year old male pt who on 07/27/2001 was vaccinated with hep A virus vaccine. On 08/09/2001, the pt was diagnosed with hep A. The nurse practitioner reported that the pt's mother took the pt to a physician who stated that the child contacted the disease ourside of U.S. The nurse practitioner also indicated that the pt had been in this country for only three weeks before he received the immunization required for school entry. Additional info is not expected.
Small red area size of nickel on 11/19/14 warm to the touch; 11/20/14 progressed to quarter size red in the middle and had a red ring (bullseye like) by 3:00pm that day it grew in size to the size of silver dollar. It was still warm to the touch. It is 3/4 of her upper arm now. She was taken to urgent care and diagnosed there with cellulitis.
On the day after vaccination, the pt developed arm tenderness. Post 36 hrs, lower back and chest achy. Post 48 hrs, lower back and chest achy, lower neck stiff, and limited ability to lift left arm.
Zoster vaccine administered 08//28/2008  A week later a blister developed on my left side. It is the size of a 50 cent piece, bright red with smaller blisters within. As of today it is still pronounced with micro blisters surounding it. The blisters have broken from friction of clothing but have never become really pussing or leaked fluid in a noticable amount.
5 Y/o M received Dtap-IPV and Varicella on his Rt lateral thigh on 15MAY2018 at 1030. Pt did not experience any symptoms the day of the vaccines. On 16MAY2018 MOP believes Pt had a mild fever, but did not take Pt's temperature. Pt states that the site is itchy and swollen. MOP brought Pt to ER around 2030 on 17MAY2018. An ultrasound was preformed and no fluid was found. MOP states that Pt received BENADRYL as treatment. Upon examination 17MAY2018  at 1000 the site is red, hot, and inflamed. Pt was discharged form the hospital at 0330 with no fever.
Severe heart palpitations the night of receiving the vaccine, followed by a constant, dull chest pain that lingered for days after the vaccine. Tested for elevated C Reactive Protein Cardio three days after receiving the vaccine.
Temperature is going up- 101; This case was reported by a consumer and described the occurrence of body temperature increased in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix. On 29th October 2019, 1 days after receiving Shingrix, the patient experienced body temperature increased. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved.   It was unknown if the reporter considered the body temperature increased to be related to Shingrix.  Additional details were provided as follows: The day before reporting, the patient received dose of Shingrix. On the day of reporting, the patient had mild side effect of temperature 101.
Pt states severe mood swings within hours of vaccine administration - tearful, agitated, sad pt describes event as "PMS like"
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N025428 exp date 19-JUN-2020) (dose and route not provided). Data digital logger was reported. The vaccine was exposed to a temperature of 47 °F to 77 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006478. US-009507513-1806USA006479:
Patient had a heavy 8 day period after a year and a half of (presumed) menopause
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient asked for event to be reported. She returned to the pharmacy 5 days after vaccine given with rash on majority of upper arm where vaccine was given. Rash is hot to the touch, itchy, and swollen. Patient advised to take Benadryl and see a doctor if it does not get better or if it gets worse. Have not heard follow up from patient since report on 10/3
"fevers and stuff"; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA ("fevers and stuff") in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal viral infection in January 2021. Concomitant products included HYDROXYCHLOROQUINE, LEVOTHYROXINE SODIUM (SYNTHROID), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FAMOTIDINE, CYANOCOBALAMIN (B12-VITAMIIN) and FISH OIL for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA ("fevers and stuff"). At the time of the report, PYREXIA ("fevers and stuff") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO treatement of medication is reported  Concomitant medication include for sleep disorder.   This case was linked to MOD-2021-331261, MOD-2021-331212 (Patient Link).
Within 1 week patient developed Miller Fisher Variant of Guillain-Barre Syndrome. On April 28 patient developed diplopia and significant weakening of body muscles. Became much worse by May 2. Worsening probably due to corticosteroids administered to reduce pain. On April 28 patient had 80 mg near nerve C6 in morning, 80 mg in left shoulder at 4 pm. Diplopia developed over the next hour.
PNEUMOVAX (Merck). Local reaction severe. Admitted to hospital for presumed cellulitis.
Case number PHEH2014US019571, is an initial spontaneous report from a health care professional received on 26 Sep 2014. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUCELVAX (batch number: 012031A) at a dose of 0.5 ml intramuscularly on 26 Sep 2014. It was reported that the vaccine received by the patient has reached 61 F for not more than 11 hours before administration. No adverse event reported following this medication error (incorrect storage of vaccine).
Case number PHEH2012US008954 is an initial spontaneous report received from a nurse on 25 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with MENVEO (batch number: M11041) intramuscularly on to unspecified site on 10 Mar 2012. It was reported that the patient subsequently experienced a seizure. He experienced a fainting episode with tonic-clonic movements within minutes after vaccination and was better within 10 minutes. The causality was not provided. No further information was available.
Deep Vein Thrombosis (DVT) left leg began 01/11/2022.  Primary care physician, Dr. , prescribed Eliquis. Clot is still present 05/13/2022, still taking Eliquis, 2x/day.
pt recv vax 30AUG95 PM; fever of 104.9, lethargy, bluish tongue, ? swollen tongue reported by father on 1SEP95 PM; rx Advil, APAP; blood culture, CBC; rx Cefzil
Client called health office to report having a "lupus flare" Reported having one for ten days after first dose, 21 days after second dose, and now ongoing still from 09/03/2021. Flare up described to nurse as  the following; nausea, headache/migraine, losing weight (estimated 12 pounds), and now feeling very tired since started the medication Reglan. Client reported letting her providers know. Client is able to communicate with Rheumatologist over mychart online. Client reported Rheumatologist has warned her it maybe a few months until the flare up gets better. Has follow up in April with provider. Educated to call and let provider know immediately if conditions worsen or with any other questions or concerns.
generalized seizure associated w/fever 104 on 9JUL98;transported to ER by EMS;lab work revealed elevated white blood count;CT of head nl;given ATB;
temperature excursion / temperature 37.94 F; Route: IM; This spontaneous report was received from a licensed practical nurse and refers to a 15 months old male patient. There was no information regarding his medical history, concurrent conditions nor concomitant therapies provided.  On 23-JUL-2021, the patient was vaccinated in a public health clinic by the reporter (described also as a trained operator) with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) first dose, intramuscularly into the left thigh, lot # T002847, expiration date 23-JAN-2022 (exact dose was not provided) for prophylaxis; the vaccine was purchased with public funds (product storage error, incorrect route of product administration). The administered vaccine was stored in a temperature of 37.94 degree Fahrenheit (F) for 100 hours. No previous temperature excursion was reported. Digital data logger was involved. No prescription drug treatment for the experience was required.  The reporter stated that the improperly stored vaccine was removed immediately after the reporting and no further vaccine was administered. The patient's parents were notified and the vaccination would be repeated with new vaccine stock.
17 hours after first dose of vaccine, nausea, loss of consciousness, cyanosis, possible seizure with muscle rigidity and choking, hypotension, bradycardia, mild concussion, liter of fluid
really cold last night; arm is really sore; fever 101; chills; headache; nausea; pain at the injection site; just feeling a little tired; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of FEELING COLD (really cold last night), MYALGIA (arm is really sore), PYREXIA (fever 101), CHILLS (chills) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included ESCITALOPRAM, ARIPIPRAZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Mar-2021, the patient experienced FEELING COLD (really cold last night), MYALGIA (arm is really sore), PYREXIA (fever 101), CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (just feeling a little tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. On 05-Mar-2021, FEELING COLD (really cold last night), PYREXIA (fever 101), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, MYALGIA (arm is really sore), HEADACHE (headache) and FATIGUE (just feeling a little tired) outcome was unknown.            Other concomitant medications include antidepressants.   This case was linked to MOD21-046823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non-significant follow-up appended On 05-Aug-2021: Non significant Follow up
screaming episode lasting several hr, large area of redness & swelling @ site of shot, sudden high (very hot) fever p/APAP given T102x48hr;
Swelling in arm, shoulder, and neck.; This is a spontaneous report from a contactable consumer. An elderly, non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient's medical history and allergies were unknown. It was unknown if prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any medication within two weeks of vaccination. It was unknown if the patient received any other vaccine within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced swelling in arm, shoulder and neck. It was unknown if since the vaccination, the patient had been tested for COVID-19. It was unknown if patient received any treatment for the events. The clinical outcome of the event swelling in arm, pain in neck and pain in shoulder was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The first night the symptoms ran all through that night and into the next night. I had a fever of 104 degrees. I was vomiting. I also had chills, I had to sleep with a heating pad to stay warm. Then I had piercing headaches that didn't go away until last night. The real high fever and vomiting lasted two days and two nights. After that it was just a fever that would only spike to 101 degrees. I had blisters on the roof of my mouth. I'm still running a fever but its low grade.
Evening after afternoon 2nd shot was worse than my worst allergy episode plus body aches Next day I had swollen throat, ear ache, headache behind eyes (Sinus?) 2nd day after eye lids and throat still swollen, shoulders and back ached 3rd day (today) was back to normal  1st shot left bad bruise feeling at injection site
Moderna Bivalent Booster was given to patient but was only given half the dose. Wrong dose given.