chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and  severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
Asymptomatic screening for admission for AKI ED to Hosp-Admission Current  6/22/2021 - present (3 days)   MD Last attending ? Treatment team AKI (acute kidney injury) (CMS/HCC) Principal problem    Review of Systems  Constitutional: Negative for chills and fever.       General weakness.  HENT: Negative for ear pain and sore throat.   Eyes: Negative for pain and visual disturbance.  Respiratory: Positive for shortness of breath. Negative for cough.   Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain and vomiting.  Genitourinary: Negative for dysuria and hematuria.  Musculoskeletal: Negative for arthralgias and back pain.  Skin: Negative for color change and rash.  Neurological: Negative for seizures and syncope.  All other systems reviewed and are negative.
asthmatic; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 26Jan2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was very asthmatic. Her second dose has been canceled twice. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial report received from a health care professional on 20 Aug 2010: On 18 Aug 2010, this child received a intramuscular dose of MenA lyophilized conjugate component of MENVEO (batch number 100022) that was reconstituted with a sterile diluent. The child had not received the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration. Follow up report received from the health care professional on 02 Sep 2010: The child had received the MenCWY-135 liquid component of MENVEO and not MenA lyophilized conjugate component as reported previously.
Breakthrough Covid + 35 year old female with a Past Medical History of Evans Syndrome, Immune Deficiency Disorder, Lymph Node Abscess, B-cell Lymphoma, Cytomegalovirus, Pneumonia, Pneumothorax, Bone Marrow Biopsy, Port, and Lymph Node Biopsy.  Admitted to Medical PCU for Low Grade Fever, COVID19, B-Cell Lymphoma, Evans Syndrome, Pneumonia, Splenomegaly, Elevated LFT's, Elevated Bilirubin, Dehydration, Hypoxemia, Tachycardia, Leukopenia, Anemia, Pancytopenia, Elevated Blood Glucose, Hyponatremia, Hypokalemia, and Questionable Small Lesions within the Liver. Patient was admitted to the hospital for shortness of breath cough and fever.  Symptoms have been progressively getting worse over last 1-2 days.
was unaware that I was pregnant when I received the first dose (I was only about 2 weeks pregnant); Swollen lymph node above collar bone on the left side, which also tender; Once swollen lymph node above collar bone on left side; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Swollen lymph node above collar bone on the left side, which also tender), EXPOSURE DURING PREGNANCY (was unaware that I was pregnant when I received the first dose (I was only about 2 weeks pregnant)) and LYMPHADENOPATHY (Once swollen lymph node above collar bone on left side) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Asthma in 1981, Depression in 2008, Anxiety in 2008, Allergy to nuts and Drug allergy. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for Asthma, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 05-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 an unknown date and the estimated date of delivery was 19-Nov-2021. On 11-Mar-2021, the patient experienced LYMPH NODE PAIN (Swollen lymph node above collar bone on the left side, which also tender) and LYMPHADENOPATHY (Once swollen lymph node above collar bone on left side). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (was unaware that I was pregnant when I received the first dose (I was only about 2 weeks pregnant)). At the time of the report, LYMPH NODE PAIN (Swollen lymph node above collar bone on the left side, which also tender), EXPOSURE DURING PREGNANCY (was unaware that I was pregnant when I received the first dose (I was only about 2 weeks pregnant)) and LYMPHADENOPATHY (Once swollen lymph node above collar bone on left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Antibiotics and Steroids   This case was linked to MOD-2021-234755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant follow up appended.
Rash within 3 days, starting on thighs and spreading over body. Sent to Dermatologist. Given steroid  cream and biopsy done. Returned to PCP 11/6/2018 with continued rash and now joint pain with swelling as well. Told to ice, compression to area and elevation.
10 hours after receiving shot she vomited 4 times and had a fever of 102.3. Temperature was back to normal within 24 - 48 hours. The mother states that there was no rash or respiratory involvement and no local reaction. The infant was alert and active but appeared tired for 24 - 48 hours.
Had ZOSTAVAX injection 2-12-09. That evening arm was very tender. His wife is a nurse, redness noted from elbow to shoulder. States arm felt numb. Had stiffness which felt like the flu. Weakness. Called 2-17-09 with this report. Was not seen. Phone contact x2 - Pt improved.
Received shot 10/18/11. 10/19/11 noticed hot red area (R) upper arm at site. 10/20/11 20x14cm hot inflamed area. Afebrile. Malaise. Not signs of systemic involvement. Tx with antihistamine/ice unless systemic s/s then antibiotics.
PATIENT ARM WAS RED AND SWOLLEN. 2 DAYS LATER STILL RED AND SWOLLEN BUT SLOWLY SUBSIDING.
Information was received from a medical assistant referring to an unknown number of unspecified patients of unknown demographics. The patients' medical history was not reported. On unspecified dates, the patients were administered dose of improperly stored VAQTA of Strength 25/0.5 (units unspecified), lot# M047658 with an expiry date of 28-OCT-2017 (Dose, frequency, and anatomical location were not reported) intramuscularly for prophylaxis. The vaccines were exposed to 27.3 Fahrenheit degree (F) for 16 minutes and 32 to 35 (31.6) Fahrenheit degree (F) for 15 minutes. There was previous temperature excursion involved which was at 32 to 35 (34.4) Fahrenheit degree (F) for 15 minutes. Digital data logger was involved. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002347:
daily headaches that last for an hour or two; Slight headache; Body temperature has not been really high but has been a little higher than normal (normally 97-98°F now 98-99.3°F); Pain in his body more than usual; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in his body more than usual), HEADACHE (daily headaches that last for an hour or two), HEADACHE (Slight headache) and PYREXIA (Body temperature has not been really high but has been a little higher than normal (normally 97-98°F now 98-99.3°F)) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pain. Concomitant products included HYDROCODONE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (Pain in his body more than usual), HEADACHE (Slight headache) and PYREXIA (Body temperature has not been really high but has been a little higher than normal (normally 97-98°F now 98-99.3°F)). On 27-Jan-2021, the patient experienced HEADACHE (daily headaches that last for an hour or two). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event following immunisation, at a dose of 2 pills. On 23-Jan-2021, HEADACHE (Slight headache) had resolved. At the time of the report, PAIN (Pain in his body more than usual), HEADACHE (daily headaches that last for an hour or two) and PYREXIA (Body temperature has not been really high but has been a little higher than normal (normally 97-98°F now 98-99.3°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (97-98): 98-99.3 (High) 98-99.3.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: ADR form received but incomplete and contained no new information.
Both FLUVIRIN 0.5ml and PNEUMOVAX 0.5 were administered in the same arm. 24 hours later severe temperature (104 degrees), vomiting, headache, swollen and infected arm where the shot was. Admitted into hospital 48 hours later as fever would not go down. Stayed in hospital for 3 days with fever.
Information has been received on 22-DEC-2016 from a third party claims management company representing a pharmacy for a case in litigation concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 17-NOV-2016, the patient was vaccinated with PNEUMOVAX23 (lot number and expiration not reported) for prophylaxis. Allegedly, the patient was given the pneumonia vaccine on 17-NOV-2016 but the patient suffered an adverse reaction after leaving the store (pharmacy) which required ambulance transport and an overnight stay in the hospital. The patient experienced but is not limited to a spike in fever of 103.5 and some swelling and redness around the injection area. The patient was released from the hospital on 16-DEC-2016 and it is unknown if additional medical treatment will be required at this time. Additional information has been requested.
patient came to pharmacy stating she has a rash on her chin, right side of chest that is itchy. I asked if she was using any new detergents,lotions,etc. Patient stated she was using a sunscreen but did not have the name. The was no redness or elevation noted at injection site. I disclosed I would be filing a Vaers report and notifying her doctor. She gave consent and verbalized understanding. Patient denied any difficulty breathing or swelling and stated was not severe enough to go to the doctor.
Patient described severe body shaking, followed by lethargy and the feeling of imminent loss of consciousness at which time her husband had to help lower her to the floor where she lay while the husband wiped her head with a cold washcloth and contemplated calling 911.  Patient gained strength after 30-45 minutes and 911 was not called. Patient went to bed and woke up with lesions/rash encompassing a significant portion of her upper arm around the injection site. All was resolved within a few days.
Information has been received from a registered nurse concerning a 57 year old male (weight 158.5#, height 69") with no known drug allergies who on 11-DEC-2006 was vaccinated with Pneumovax 23 (lot #651401/0619F), 0.5 ml, IM i the right deltoid. Concomitant medication included CHIRO
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's sister on 24-APR-2012 at 10:00 AM, was vaccinated with a third dose of VARIVAX (Merck) in right upper arm, lot number reported as "143AA" (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an approximately 27-APR-2012 (3 days later), the patient's sister developed same rash (no vaccines) (reported as rash on trunk, rash not painful). No treatment information was reported. At the time of report, the outcome of the patient's event was unknown. The relatedness for the patient's event was not reported for VARIVAX (Merck). This is one of several reports from the same source. Additional information has been requested.
Patient reported a small amount of redness and swelling approximately 4 hours after receiving injection. Approximately 10 hours past injection, patient described erythema, warmth, hardness and swelling from shoulder to elbow on left arm slightly below injection site. Symptoms to resolve within 18 hours after injection. Treated with cold pack and Tylenol.
Information has been received from a CMA concerning a female pt with no allergies and no past medical history who on 08/14/03, was vaccinated SC with a 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 644220/1119M). There was no concomitant medication. Subsequently, in August 2003, the pt developed slight pain. Later in August 2003, the pt had an "allergic reaction" and went to the ER. On 08/26/03, the pt developed site pain, redness around the site and felt like the area was a bruise. On 08/26/03, the pt returned to the medical office, but she did not require any medical attention. No lab tests were performed. Subsequently, the pt fully recovered. A product quality complaint was not involved. The reporter also mentioned a second pt that had a similar reaction post vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644220/1119M)(WAES # 0308USA02694).  Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (lot # K004795 with expiration date: 11-FEB-2016), (strength, dose, frequency and route were not reported), which was improperly storage. No adverse events were reported. Additional information has been requested.
Mom said pt. had "passed out on last vaccine". So after giving 2nd HPV, I instruct pt. to laid down for a few minutes, she said she was ok but still she stay there resting for awhile. When she was walking out (in the lobby) mom states she was gonna "pass out" again, shake slightly.
I got a Janssen/Johnson & Johnson vaccine on 3/6/2021. On the morning of 3/8/2021, I experienced a nosebleed, which was unusual for me, as I am not prone to nosebleeds. For about 3 days I experienced nosebleeds, which weren't very heavy and didn't last long. I also had headaches for about a week. Since the nosebleeds and headaches weren't severe, I didn't seek medical attention for them. In May 2021, I noticed that the moles on my back, arms, legs, and stomach had all either disappeared and left behind white spots in their place or else were still present but fading. I saw a dermatologist on 10/19/2021. He explained to me that they were halo nevi and that their disappearance was an immune response to either cancer or the vaccine I had received. He also mentioned that halo nevi sometimes accompany vitiligo, but he said that I definitely did not fit the diagnostic criteria for that condition.  I was given a full-body screening for cancer, and none was detected. I am scheduled to undergo another screening in April 2022, though the dermatologist is confident that I don't have cancer.
Skin reaction at vaccine site approximately 10 days after first dose (e.g. raised lump with bumps; red and itchy).  Afew days later, I then got a slight sunburn on arm and the vaccine injection site lump was worse than the rest of arm. Site peeled multiple times to reveal skin that was still bumpy and red.
patient was administrated with an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: The medical assistance reported on 10th October 2022 that the patient was administrated with an expired dose of Havrix on 7th October 2022. The vaccine expired on 30th September 2022.  No adverse event was reported. The consent to follow up was granted.  Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 16-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032317, expiry date: 22-SEP-2022 (strength, dose number, route and anatomical location were not provided) for prophylaxis.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of 6°F to 14°F (8.5° F) for 0 hours l8 minutes O seconds; 6°F to 14°F (l l.9F) for 1 hour 0 minutes 0 seconds with a cumulative Timeframe: 1 hour and 18 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint was involved.
Talk to pt. She had flu like symptoms, body pain. Shivering after 3-4 hrs of vaccination on 9/22/19. on 9/23/19 at 2:30 PM she is feeling ok. No shivering, just body pain, Dr told to take Tylenol
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Patient reported redness, swelling, and soreness to the area. She reports that the redness then spread down her arm. When I looked at her arm a week from the date she received it. There was bruise like redness below her elbow. The point of injection side had no swelling or redness.
patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine.
2;27 pm on 2/23 vaccine receivee; waited 30 minutes and had "shakes", but guessing it was just me, not the injection.     Awoke at 3AM on 2/24 feeling achy and very sluggish and had chills.  Fell back to sleep. 7:30AM, temp was 99.4 and I took Advil, 2 tabs, body aches and chills.   8:30 AM, feeling better, temp 99.3, not so achy.  Left arm below injection site looking slightly red and blotchy. 3:30 PM, temp 99.6 feeling achy and took 2 Advil and slept for nearly 3 hours.   Woke at 6:15PM, feeling tired.  7PM, temp 100.4, took 650 mg of Tylenol and went to a Zoom meeting.   9:00 temp 98.5, feeling more normal.   11:00 PM until 6:30AM slept well, no elevated temp, but my left arm is very red, blotchy about an inch below and to the right of the injection, 1.5 inch in diameter, not a perfect circle, warm to touch and tender.   This was my second injection of the Moderna Covid vaccine and I had No reactions with the 1st injection, except a bruise at the site.  Both injections given in the same arm; 28 days apart.
A wife reported that her 65 yr old husband received an injection of Flu Shield 2000-2001 formula in late November 2000. In January 2001, he developed facial paralysis, numbness, and dizziness. She indicated that her husband related these symptoms to the Flu-Shield. The reporter stated that her husband has recently been dx with a slight elevation in hypertension and was prescribed Atacand. Additional information received from the pt, a physician , on 05/21/2001 indicated that in addition to those symptoms reported by his wife, he is experiencing tremor, foggy memory, blurred vision, and a feeling of heaviness in his face, particularly around the orbital muscles. The pt has consulted with several physicians and stroke was ruled out.
A rash developed on my upper left arm around the site of the injection.  Started about 36 hours after injection and has receded to some extent now.
Patient presented to pharmacy to get a COVID booster shot. It was  not caught that her first two doses of the vaccine were Moderna until after a Pfizer shot was already administered.