chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient reported an incorrect DOB, which lead us to believe that they were 18 or over,  therefore given their first dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over,  therefore given their first dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over,  therefore given their first dose.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over,  therefore given their first dose.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided by the reporter Treatment information was not provided by the reporter. No lab data was provided by the reporter.
10 year old given monovalent booster instead of bivalent; 10 year old given monovalent booster instead of bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (10 year old given monovalent booster instead of bivalent) and NO ADVERSE EVENT (10 year old given monovalent booster instead of bivalent) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1) on 04-Nov-2021, Pfizer (Dose Number: 2) on 21-Jan-2022, Pfizer (Dose Number: 3 and Lot number: FL8095) on 23-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 13-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (10 year old given monovalent booster instead of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (10 year old given monovalent booster instead of bivalent). At the time of the report, WRONG PRODUCT ADMINISTERED (10 year old given monovalent booster instead of bivalent) and NO ADVERSE EVENT (10 year old given monovalent booster instead of bivalent) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (10 year old given monovalent booster instead of bivalent) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (10 year old given monovalent booster instead of bivalent).    No concomitant drug were reported.   The pharmacy technician stated that the pediatric dose was approved.   No treatment drug were reported.
Admit date: 11/28/2022  Discharge date : 11/30/2022   Antepartum complications: prolonged rupture of membranes                                                   Delivered By: facility staff   Primary Diagnosis: Forceps delivery
Approx 10 min. after injection, pt became hot, faint feeling and pale. B/P 84/58, P 72, R 20. Laid down on cot with feet elevated, cool cloth to head and fan. After 20 min, color improved BP 80/60, P 64 but still lethargic. At 50 min tired but alert BP 80/60.
Within 1-2 minutes of patient receiving flu shot, husband returned to pharmacy asking for pharmacist help with his wife. Upon arrival patient was having trouble breathing despite being on oxygen. Per guest request I called 911 and advised pt to take slow deep breaths per 911 agent.  Per patient/husband, she has has flu shot in past with no reaction. Her husband said she has been battling attacks like these for years for COPD/anxiety and he thought she was having another COPD attack, not a reaction to flu shot.  Pharmacist stayed with patient until paramedics arrived and took over.
Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose #1 03/30 Pfizer, dose #2 08/23 pt cc: chills, cough, diarrhea, fever, headache, loss of taste or smell, myalgias, rhinorrhea, dyspnea, shore throat exposure; unknown 08/24 COVID swab, result: detected 08/24 SARS-COV-2 Variant Sequencing result; pending 09/02 clinically resolved
PT HAS A RASH BEGINNING UNDER HER LEFT ARM AND TRAVELING DOWN HER SIDE BEGINNING AT 1AM ON 6/20/22.  THE PAIN WOKE HER UP AND ANYTHING TOUCHING THE RASH HURTS.  SHE WILL GO TO THE DR ON 6/22/22 AT 9:20AM
Severe reaction with histamine response and rash to arms, neck, face, and spreading to legs
Mother had the shots and still got shingles/ suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother got shot and still had shingles and pain. The reporter stated that, the physician could not seam to have her any thing to help. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
I received my 4th booster shot for COVID-19 on 11/01/2022 at 8:00AM. I wasn't feeling well. It started getting worse and worse. I was feeling very tired. I had a headache, lack of energy,  problems with throat( cough), and fever. I tested positive for COVID-19 on 11/03/2022.  On the following day  I contacted my doctor on 11/04/2022. My doctor prescribed me with Paxlovid for 5 days and Advil once a day.
This case was reported by a physician and described the occurrence of a male subject aged between 60 and 69 years old testing hepatitis B surface antigen positive following vaccination with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The subjects medical history and concurrent conditions were not reported. Concurrent medications included blood pressure medications. In October 2006 the subject received primary course of Engerix B at 40 mcg. Lot number and expiration date were not reported. In November 2006, following vaccination with Engerix B, the subject was tested and found to be hepatitis B surface antigen positive. The event was unresolved at the time of reporting.
Vaccine administered 2/24/16; 3/2/16 - stiff and sore low back, pain in back; 3/5/16 - fever 100.8, chills, night sweat, general feeling unwell w/body aches through 3/9/16; 3/8/16 - Rash developed on abdomen, back, spread to legs, chest, face.
Moderate to severe local reaction began a few hrs. after receiving immunization & gradually worsened. Had redness, edema and warmth in the next 2 days. Sent to see her PCP. Tx, cold pack, Benadryl. Local rx in rt upper arm, inject.site down
EAR ISSUE SURGERY/RECONSTRUCTIVE AND REMOVAL SURGERY ON LEFT EAR; RHEUMATOID ARTHRITIS FLARE UP; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date in June 2021, the patient experienced COVID. On an unspecified date in AUG-2021, the patient had experienced covid (suspected covid-19 infection) and on an unspecified date in NOV-2021, the patient experienced the covid for the third time and had recovered from it. He also had strep throat at the same time of covid in NOV-2021.  On an unspecified date in JAN-2022, the patient had experienced rheumatoid arthritis flare up and she was treated with steroid. On an unspecified date, the patient experienced ear issue surgery/reconstructive and removal surgery on left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with upadacitinib was not reported. The patient recovered from ear issue surgery/reconstructive and removal surgery on left ear, and suspected covid-19 infection, was recovering from rheumatoid arthritis flare up, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number: 90000216853.; Sender's Comments: V0:20220222629-COVID-19 VACCINE AD26.COV2.S-Rheumatoid arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220222629-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a nurse concerning a 19 year old female with no pertinent medical history, allergies or drug reactions, who on 20-OCT-2008 was vaccinated with the first dose of GARDASIL (lot no. 661044/0548X) 0.5 ml, IM. There was no concomitant medication. On 20-OCT-2008, two hours after vaccination, the patient had a seizure. The patient had no history of seizures. The nurse thought the patient may have gone to the emergency room. The physician had attempted to reach the patient's mother but has not gotten in touch with her yet. Upon internal review seizure was considered to be other important medical event. Additional information has been requested.
On day 7 post vaccination, injection site is red and painful. Also pain in left axilla. Current observation only.
mom reports that p/1st set of vax pt devel fever t105, pt taken to ER tx for fever, released home p/temp come down, no other problem;
Chills, temp. 104, swelling, pain, knees, hands and ankles, rash over entire body.  Fever 3 days, swelling 12 days, rash 3 days
husband's body fight COVID & only have mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (husband's body fight COVID & only have mild symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (husband's body fight COVID & only have mild symptoms). At the time of the report, COVID-19 (husband's body fight COVID & only have mild symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 fever diagnosed with COVID.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.; Sender's Comments: Covid infection following vaccination has a causality assessment of "not applicable" by convention.  The patient's wife indirectly reported that her husband's Covid infection was only mild due to receiving the vaccine. No date of vaccination or onset date of Covid was provided.  Event of Covid-19 captured conservatively as the implication of the report is that the infection occurred after vaccination.  No event of lack of effect captured as it is now known how long after vaccination the infection occurred
Patient reported that some time after receiving the vaccines they experienced paralysis and numbness in their right arm. Patient went to doctor and was found to have no pulse in right arm. Patient was transported to ED then hospitalized 3 days. Patient reported a blood clot and blood infection in right arm. Infection was treated with antibiotics for 3 days.
has been having a lot of pain; sharp pain in her back; sharp pain in her left arm; sharp pain in her left hand; sharp pain in her shoulder; sharp pain in her left wrist; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (has been having a lot of pain), BACK PAIN (sharp pain in her back), PAIN IN EXTREMITY (sharp pain in her left arm), PAIN IN EXTREMITY (sharp pain in her left hand) and ARTHRALGIA (sharp pain in her shoulder) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METHOTREXATE SODIUM (METHOTREXATE [METHOTREXATE SODIUM]), PREDNISONE, FOLIC ACID, INFLIXIMAB, ACETYLSALICYLIC ACID (BABY ASPIRIN), POTASSIUM (POTASSIUM 99), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), LATANOPROST, TIMOLOL MALEATE (LATANOPROST & TIMOLOL MALEATE) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (has been having a lot of pain), BACK PAIN (sharp pain in her back), PAIN IN EXTREMITY (sharp pain in her left arm), PAIN IN EXTREMITY (sharp pain in her left hand), ARTHRALGIA (sharp pain in her shoulder) and ARTHRALGIA (sharp pain in her left wrist). The patient was treated with PREDNISONE at an unspecified dose and frequency and CORTISONE at a dose of cortisone shot given. At the time of the report, PAIN (has been having a lot of pain), BACK PAIN (sharp pain in her back), PAIN IN EXTREMITY (sharp pain in her left arm), PAIN IN EXTREMITY (sharp pain in her left hand), ARTHRALGIA (sharp pain in her shoulder) and ARTHRALGIA (sharp pain in her left wrist) outcome was unknown.            .The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Neurological breakdown; extreme tremors; ED visit and hospitalization over 72 hours following vaccine.  Tremors caused fall which resulted in facial cuts; neurological event caused inability to identify date and age, fever of 103* and cellulitis at injection site
A sales representative reported that a 2 year old child received 2 doses of Prevnar and had pre and post vax sero-types drawn. Titers showed no level of response. The pt's medical history indicated that the child is "highly resistant to strep pneumonia". As of 12/15/00, no further information was available.
Systemic: Dizziness / Lightheadness-Medium, Systemic: really over heated-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Gave patient cold water glucosetablet and took blood pressure. 118/70.patient felt fine after 5 min and left
Patient described receiving rabies #2 vaccine on November 14, 2014 (Novartis pharmaceuticals, lot #541011A, 1mL IM in the left arm). Of note, he described receiving the vaccine very high on the arm very close to the acromion process. He endorsed immediate onset tightness of the left arm that progressed over the next 2-3 days and began to significantly limit his range of motion. He described normal activity such as turning the steering wheel or placing deodorant caused significant discomfort. He described a constant pain 2/10 in intensity with significant exacerbations up to 7-8/10 intensity with certain motions. He denied any true weakness of the arm. He denied any associated rash, urticaria, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. Additionally, he denied any associated fevers, chills, night sweats, nausea, vomiting, diarrhea, generalized muscle aches/pains or synovitis. He was treated with MOTRIN for his symptoms which partially relieved the pain, but upon discontinuation the pain returned with increased intensity.
Patient white count has been lowered.; This is a spontaneous report from a company program.  A contactable other HCP reported for a patient of unspecified identifiers received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No patient identifiers were provided but the reporter has first but had knowledge of the patient reported on a specific patient. Nurse practitioner reported for patient who got covid vaccine. Patient white count had been lowered. The patient underwent lab tests and procedures which included white blood cell count: lowered on an unspecified date. Outcome of the report was unknown.  Information on the lot/batch number has been requested.
On 9/8/00, the pt developed 12-15 bumps/spots mainly on face, trunk, and a few on arms/legs and also a fever. No treatment required per physician.
Awoke congested with sinus pressure and a runny nose.  Throughout the day this has progressed to nausea, dizziness, intense fatigue, and headache at present.  I have slept most of the day, but symptoms continue to worsen.
Extremely enlarged lymph node under left armpit size of tennis ball after first dose, size of baseball after second and third doses, lasting 3-4 weeks each time. Menstrual cycle completely haywire, several months twice a month, heavier than normal, extremely large clots.
Sent to hospital on 1/11 from nursing home with O2 saturations found in the 70's on 3 L O2 with 94% saturation. Covid + on 1/1 and had been in isolation. Admitted with pneumonia, A fib with RVR and sepsis. Gvien antibioics and cardizem drip. Started Iv giursis. 1/13 thoracentesis removing 1.8 Liters. 1/14 trasnferred to critical care due to hypotension and reaccumulated right pleural effusion. Place on vapotherm due to hypoxic respiratory failure.  Vaso pressors and steroids started. Remained COVID +. No DVT and started on heparin. Worensing renal failure and hyperkalemia.  Met with family on 1/16 about continuing deterioration. 1/17 family requested comfort care.
Sore arm as site, then chills, and Headache, and feeling of unwell.   Then ache joints.  Lost of appetite and nasuea. and fatigue.   Headache, and feeling of unwell ache joints lasted about 24 hour.   Lost of appetite lasted about 3 days,  Fatigue still have at day 6.   Left arm lymph nodes started hurting and swollen about 48 hours after and lasted for 3 days.
p/recv vax pt exp swelling, tenderness, stiff & sore arm, red.
on lot 022821A   shot #2   headache, chills, sleepy.     Headache into next day the other symptoms gone.
Member received Anthrax #6 1Nov08. Presented to clinic 4Nov08 with complaint of erythema, edema, pain, decreased range of motion, and tenderness radiating from the top of his shoulder to the middle of his forearm. Member sent to urgent care for treatment. Member returned with a diagnosis of cellulitis.
It started with a scratchy throat, congestion, fatigue. The symptoms were mild. I also got PAXLOVID on the same day I was diagnosed. Symptoms lasted for 5 days.
This is one case out of a cumulative total of 242 cases solicited from the database during the surveillance period from 01 January 2010 to 16 December 2014. These 242 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 16 December 2014 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received 3 doses of PENTACEL; lot number C4478AB received on 31 October 2013, lot number C4577AA received on 31 December 2013 and lot number C4538AA received on 24 February 2014 (routes and sites of administration not reported). The subject developed cold-like symptoms on 11 October 2014, approximately seven months after the last dose. On 11 October 2014, the subject developed a cough and paroxysmal cough on 13 October 2014 without a whoop. The subject also experienced sleep disturbance. The subject did not experience post-tussive vomiting or apnea. Laboratory testing included positive PCR on 18 October 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 27 October 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Electric like wave shot to my brain while driving home from work, feeling of panic and restlessness, high blood pressure, have been diagnosed with sever panic attacks months afterwards, feeling of pin and needle skin, feeling like a visitor in my own body, having cold sensations followed by feeling of disorientation and feeling like I could pass out, unable to focus at times, smell of pizza or pickles makes me nauseous, having feeling of random adrenaline rushes, nausea and vomiting at random times, feeling of pressure headaches at random times, symptoms seem to be at their worst when driving or late at night
UTI; too sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI"; ILLNESS (non-serious), outcome "unknown", described as "too sick". The lot number for bnt162b2 was not provided and will be requested during follow up.