chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. DOH notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from DOH are to notify all of the recipients that received an incorrect dose and submit an agency report for each.
Fever chills (felt very cold, shivering).  Muscle aches from sole of feet to scalp. Symptoms lasted until 03:00 AM (4 hours duration). Symptoms faded in intensity over next hour until gone.
irritable; baby was not eating much; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and non via health care professional via the Agency number: 00809296.  This case involves a six months old male patient who was irritable (irritability) and baby was not eating much (decreased appetite) after receiving DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)].  The patient's medical history, past medical treatments, vaccinations, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation prophylactic vaccination respectively.  On 06-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number: UJ496AB and expiry date: 29-MAY-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  On 06-OCT-2021 the patient developed a non-serious events irritable (irritability), baby was not eating much (decreased appetite) on a same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  No lab data was reported.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the event outcome was Unknown from the events.
After 8 days a large red, itchy rash developed around the site of the injection on the left arm.
This case was reported by a nurse via sales rep and described the occurrence of fainting in a adolescent male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO, the patient experienced fainting. On an unknown date, the outcome of the fainting was unknown. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccination was not reported. The nurse reported to the sales representative that, the patient after receiving BEXSERO experienced fainting. The reporter did not have any other information to report.
I received my 5th dose on 09/29/2022. My COVID-19 infections symptoms started on 12/23/2022 in the morning around 08:00AM. I had a runny nose, severe headache, and tightness in my chest. I called my doctor on Friday morning he prescribed me with PAXLOVID for 5 days. On 12/23/2022 I did a COVID-19 home test which was positive then I called my doctor to inform him about my positive test.
soreness of arm; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (soreness of arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INJECTION SITE PAIN (soreness of arm). At the time of the report, INJECTION SITE PAIN (soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt exp high fever 104 w/jerking during night of 6JUN91, lethargic, not eating & vomiting AM 7JUN91; Seen by MD next day & dx hyporesponsive to Pertussis vax;
Breakthrough case admission after 3 vaccines Janssen 10/4/21 Lot# 1822809;  Moderna 1/18/22 Lot# 030H21B;  Modena 8/2/22 Lot# 011B22A
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 20th of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm  when and if patient should receive the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
08/29/22 presents to ED for "abdominal pain". PMHx of "GERD, gastric ulcers, HTN, and HLD"
Guillain-Barre Syndrome; This is a literature report for the following literature source(s): (privacy).  Case Diagnosis: Guillain-Barre Syndrome (GBS) was diagnosed in a female with symptoms of ataxia, paresthesia, and dysmetria, which was confirmed with cerebrospinal fluid (CSF) analysis. Case Description: We present a case report about a 34-year-old female who developed GBS two weeks after receiving the first dose of the Pfizer COVID-19 vaccine. Setting: The diagnosis was made in the acute hospital, and then treatment continued in the acute rehabilitation setting. Assessment/Results: Results from the CSF analysis were conclusive with physical presentation, and the patient was started on the proper treatment protocol, which included IVIG and high-dose steroids. She continually made progress during her rehabilitation period, and an electromyography (EMG) and nerve conduction study (NCS) was scheduled as an outpatient for better confirmation. Discussion: In 1976, there was substantial evidence of a causal link between the swine influenza vaccine and the development of GBS. Thus, the Vaccine Adverse Event Reporting System (VAERS) was then established in 1990 as a system that has helped detect any safety problems with any vaccines. To date, the VAERS has reported four cases of GBS after the 1st dose and three cases reported after the 2nd dose of the Pfizer COVID-19 vaccine. Our case will be the fifth reported case after the 1st Pfizer vaccine dose. Conclusion: It is important to note a patient's past medical history in the acute rehabilitation setting, including any recent vaccinations. This is because the VAERS requires that all healthcare professionals report adverse events, and all vaccine manufacturers must disclose any adverse events reported to them.; Sender's Comments: Based on the temporal relation, the association between the event of Guillain Barre syndrome and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Large mass to arm with thrombotic thrombocytopenic purpura, warm to touch, increase in redness and swelling; no drainage.
I have COVID arm; I have COVID arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "I have COVID arm".  Additional information: Just wanted to thank you for all the COVID vaccines. Every time I have COVID arm. However, this time with the new booster my COVID arm red mark was in the shape of a heart. So even my body expresses it love. Would love to share a picture.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After receiving my 2nd dose of Covid-19 mRNA vaccine/Pfizer/Bio NT vaccine EUA on 1/13/21 at 1000am I experienced symptoms of severe headache that resulted in a subjunctival hemorrhage of my right eye and asymptomatic new onset hypertension.
Expired vaccine used-beyond use date of 15 Jan 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.   No Medical History information was reported.    On 20-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant  medication was not reported. Treatment medication was not reported.  Moderna vaccine was pulled from freezer on 16-Dec-2021. Beyond use date of 15-Jan-2022 was printed in red and taped to the top of boxes. On 26-Jan-2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31-Jan-2022, Moderna confirmed that revaccination was not required.
17MAR93 sluggish, started to vomit; to MD; 18MAR93 sleepy; MD stated no more Hep B shots due to allergic reaction;
pt recvd vax & began v continuously, was weak;to er via ems; adm x 2 days; final dx:vomiting(cause unk), premature thelarche;
72yo patient was ordered to be given Prevnar vaccine at well person exam, she had been given PCV23 in 2016 so needed a PCV to complete her care gap. Provider verbally gave order for Prevnar, order was not placed in electronic record prior to the vaccine administration. As the nurse, I chose the wrong Prevnar, I administered Prevnar 13 instead of Prevnar 20 to pt. Went to document vaccine given and flag came up in electronic record that Prevnar 13 was inappropriate to give pt. Provider notified. Clinic supervisor notified.
Severe Muscle and Joint inflammation with pain.  Neck, Shoulders, Arms, Knees and ankle bones and bottoms of both feet.  Left knee doubled in size.  Pain extends to midway up the back of  head.  Was referred to PT unable to continue due to nerve pain.  Lymph node swelling and pain on the left side under chin down the neck.  Unable to turn my head w/o discomfort.  I was a very active person prior to the vaccine.
Information has been received from a retired physician concerning his granddaughter who was vaccinated with a 2 ml oral dose of Rotateq. Subsequently the patient was treated for intussusception. It was reported that a barium enema was performed. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information is not expected.
Three days after the 2nd vaccine injection I started experiencing muscle weakness in both legs and arms.  To navigate stairs in my home I use a banister on both sides, not much difficulty.  Since Monday, 3/15/2021,  I have much more difficulty using my walker, navigating stairs, getting in and out of cars.
Diffuse Urticarial rash, worsening day 3 despite PO dexamethasone, Allegra, Zyrtec and Benedryl. Received IV benedryl due to swollen lips in the ER.
On 10/21/10 child was referred by school nurse for school immunization. On 10/21/10 11:10 AM, received telephone call from parent that child had broken a red rash/hives "to face and upper chest. No fever and breathing normal. If ok to give BENADRYL liquid. Sr. PHN recommended BENADRYL liquid according to body wt. and if s/s did not decrease, to take child to ER. Father agreed.
Within 10 minutes of receiving the immunization, the patient got flushed, hot, dizzy, blurred vision, and vomited. The symptoms resolved with time, water, and ice packs. Her primary care provider was notified immediately, but they did not think she required any further medical attention, as the adverse events dissipated in 20-30 minutes. Patient left facility with her mother as the driver. She was counseled to eat some food, take ibuprofen, and rest. She was also advised to immediately seek medical attention if she begins to feel bad again, or breaks out into hives or has trouble breathing.
Covid shot # 1 04/06/21 , I waited 20 minutes, and I had painful nerve like bite marks on each arm after receiving my first Covid shot. 2nd Covid shot Around 1:00 AM developed a fever and woke up from a sound sleep with head neck, shoulders and bilateral upper extremities tremors. Call an ambulance and went to the Hospital.  Where they treated me. with IV fluids, Ibuprofen and Tylenol and volume. Went home with Valium to take at night.
Mother called clinic and stated child received shots around 2 hours previously and she noted "hives" breaking out on wrists and behind ears. Mom stated rash appears to be spreading. No difficulty breathing per mom. No other sxs.
On April 1, 2021 I received the first dosag of the Moderna. I left there and was fine, but on Saturday April 3, I began to swell. It started off looking like an insect bite, but as the day progressed, the bumps became knots that were painful and itchy. On April 4, I was in a lot of pain causing me not to be able to use my left arm so I did a virtual visit with Urgent Care. I was told I was experiencing the "Covid Arm" and to take Benadryl for the itching and bumps and Ibuprofen for the inflammation and pain, and to sit out of work. After a few days of  the Benadryl I experienced the next outbreak on April 6, and I used the virtual visit again, I was taken out of work and told to continue the Benadryl but to take it 3 times a day. Again, Benadryl worked a few days and on April 12th I had another breakout on my face, causing pain, swelling and discoloration. The doctors prescribed Prednisone and continued Benadryl. I took that for 5 days, and on Sunday April 18, I had the most recent breakout. I went to a dermatologist on 4/19 and was given triamcinolone cream, allegra and benadryl. I have to return in 2 weeks to be examined again. This allergic reaction has been ongoing for 19 days, and counting.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On unknown dates between 01-JUN-2015 and 15-JUL-2015, the patients received improperly stored ROTATEQ (dose/doses in series were unspecified, lot # K015816, expiration date 29-MAY-2016) orally. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Achy feeling in limbs, rash around site and fingers hurt when made fist. Next day arm swollen around site (raised 1" in about 4-5" area). Headache, no rash and no achiness today.
Approximately 14 hours after receiving second dose of vaccine had severe body aches and chills, uncontrolled shaking for 6hrs, tachycardia, fever 103, joint and muscle pain, severe headache, fever did not respond well to tylenol taken, lowest got was 101.9. Continued to remain symptomatic until present day 02/03/2021 with body aches, severe headache and 102 fever. Had to call in sick to work 02/03/2021. Called  Covid hotline and they advised me to complete this form and to notify them if not better by 02/04/2021 or go to urgent care if fevers remain still tomorrow.
Patient felt uneasy after the shot. After a few minutes once he started walking, he fainted. He was out for a few seconds. He gained conciousness after and rested for a bit with water.
DEVELOPED SHORTNESS OF BREATH WITHIN 10-14 DAYS OF RECEIVING COVID BOOSTER. PATIENT WAS ADMITTED TO a local MEDICAL CENTER ON 10/3/2022 AFTER CT CHEST SHOWED PULMONARY EMBOLI.
Chills; not have appetite,; have chest pain, it feels like heavy chest patient had experienced this symptom before the vaccine, but this one is a bit harder; have chest pain, it feels like heavy chest patient had experienced this symptom before the vaccine, but this one is a bit harder; has more trouble walking,; felt sleepy; has a bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DECREASED APPETITE (not have appetite,), CHEST PAIN (have chest pain, it feels like heavy chest patient had experienced this symptom before the vaccine, but this one is a bit harder), CHEST DISCOMFORT (have chest pain, it feels like heavy chest patient had experienced this symptom before the vaccine, but this one is a bit harder) and GAIT DISTURBANCE (has more trouble walking,) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ROSUVASTATIN, CALCIUM, IRON (CALCIUM & IRON), MECLIZINE HCL, CLONAZEPAM and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (Chills), DECREASED APPETITE (not have appetite,), CHEST PAIN (have chest pain, it feels like heavy chest patient had experienced this symptom before the vaccine, but this one is a bit harder), CHEST DISCOMFORT (have chest pain, it feels like heavy chest patient had experienced this symptom before the vaccine, but this one is a bit harder), GAIT DISTURBANCE (has more trouble walking,), SOMNOLENCE (felt sleepy) and INJECTION SITE MASS (has a bump at the injection site). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), DECREASED APPETITE (not have appetite,), CHEST PAIN (have chest pain, it feels like heavy chest patient had experienced this symptom before the vaccine, but this one is a bit harder), CHEST DISCOMFORT (have chest pain, it feels like heavy chest patient had experienced this symptom before the vaccine, but this one is a bit harder), GAIT DISTURBANCE (has more trouble walking,), SOMNOLENCE (felt sleepy) and INJECTION SITE MASS (has a bump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
ended up in ICU due to her esophagus; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL DISORDER (ended up in ICU due to her esophagus) in a 35-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced OESOPHAGEAL DISORDER (ended up in ICU due to her esophagus) (seriousness criterion hospitalization). At the time of the report, OESOPHAGEAL DISORDER (ended up in ICU due to her esophagus) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment medication details reported. It was reported that patient had the first dose of Moderna in Feb2022 but got seriously sick and ended up in ICU due to her esophagus which was mentioned unrelated to the covid19 vaccine. Company Comment:  This is a spontaneous case concerning a 35-year-old female patient with no medical history reported, who experienced the unexpected serious event of Oesophageal disorder, which led to hospitalization, on the same year after receiving the first dose of mRNA-1273 vaccine. Patient also received an expired mRNA-1273 vaccine as second dose, approximately 4 months after the first mRNA-1273 vaccination. It was reported that the patient got seriously sick and was admitted in the ICU due to unspecified disorder of the esophagus. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-602866 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 35-year-old female patient with no medical history reported, who experienced the unexpected serious event of Oesophageal disorder, which led to hospitalization, on the same year after receiving the first dose of mRNA-1273 vaccine. Patient also received an expired mRNA-1273 vaccine as second dose, approximately 4 months after the first mRNA-1273 vaccination. It was reported that the patient got seriously sick and was admitted in the ICU due to unspecified disorder of the esophagus. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Initial report received from a health care professional on 07 September 2010. A 58-year-old female patient, with a history of Bell's palsy, received on 20 August 2010 an injection (route and site not reported) of ADACEL, lot number C3486AA. On 21 August 2010, the patient called in the morning to report that she had a temperature of 103 (units not provided), "knot in arm" and warm to touch at site. The patient was advised to take ibuprofen. The patient came to workplace on 23 August 2010 ("10/23") with a doctor's note which stated the patient would need to be off work because of a flare-up of her Bell's palsy. The patient reported having one side of her face down and one side up and reported eye twitching. The patient had no relevant diagnostic tests performed. The outcome was reported as unknown. Documents held by sender: None.
Severe pain to the left shoulder, rigors, fever, no rash or swelling at injection site.  Patient was given ZOSYN 3.275 g IV after blood culture x2. Elevated WBC and CRP.