chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented with CP, productive cough, congestion; + covid ED; Admit OBS 9/24 Tele; inpatient admit 9/25 tele; tx with 9/24   lovenox, singulair, zinc started; O2 requirements:  room air
Clarified and confirmed that patient received 4 total doses of the Pfizer COVID-19 vaccine/Received 4 total doses of the vaccine and then got COVID; Clarified and confirmed that patient received 4 total doses of the Pfizer COVID-19 vaccine/Received 4 total doses of the vaccine and then got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Clarified and confirmed that patient received 4 total doses of the Pfizer COVID-19 vaccine/Received 4 total doses of the vaccine and then got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated she filled out a safety report. The consumer (Patient's mother) reported for a female patient (daughter). Caller was calling about Paxlovid. Patient was a young adult. Caller needed an explanation, caller and patient were concerned about patient's condition. Patient got all of the shots, patient was fully vaccinated. Clarified and confirmed that patient received 4 total doses of the Pfizer COVID-19 vaccine. Caller's daughter, the patient, lived in another state and patient got COVID and was prescribed Paxlovid and took the medication. But once the patient finished taking the medication the patient began getting very thirsty and excessively thirsty. Patient was always thirsty. Patient was going to the doctor tomorrow. Patient had been excessively thirsty for 2 weeks, was constantly having to drink something and had dry mouth. Caller and patient didn't knew the medication wasn't FDA approved. Caller was calling to report that and get information from Pfizer to see whether Pfizer was getting calls in regards to patients getting very thirsty. Caller had asked around to friends and family who had taken the medication. Declined to provide additional reporter details or complete a report, requested to get transferred a site for caller's question. Is there a product complaint to report? Yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN concerning a 36 year old white male food service worker with allergies to egg, protein, milk, latex-based paint and "other environmental allergies of different sorts" (the pt denied any medication allergies) who on 08/27/03 in the AM was vaccinated ID (also reported as SC) in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644107/0955M). The pt had presented for Mantoux skin test that was required for his pre-employment work-up, but was accidentally given pneumococcal vaccine 23 polyvalent ID by mistake. Subsequently, the pt developed a site reaction in the left arm that included a red, swollen and warm injection site. On 08/29/03, the pt was referred to the department of health for a "positive Mantoux skin test" and was seen by the reporting nurse. The pt's left forearm was very edematous, firm, red, tender to touch, with vesiculation at the injection site. The arm were the injection was given was also described as having a hot, red and warm area from the wrist to the elbow. The onset date was noted to be 08/28/03 in the PM. The reporter noted that the pt had a "dramatic reaction" to pneumococcal vaccine 23 polyvalent, not a positive Mantoux or reaction to tuberculin was originally thought. The pt went to the ER for treatment and an antibiotic was given. Within one week, the pt recovered. A product quality complaint was not involved. Additional information is not expected.
This spontaneous report was received from a physician and refers to an approximately 38 year old male patient with no pertinent medical history and no drug reaction/allergy. Concomitant therapies included losartan potassium (manufacturer unknown), metoprolol and aspirin. On an unknown date, when he was a child, the patient was vaccinated with M-M-R II (therapy type: HSA, dose, route of administration, lot number and expiry date were not reported). On an unspecified date in 2003, the patient had a mitral valve repairment due to an unknown event. In approximately 2003, the patient was hospitalized in the reporting physician's hospital. the outcome of an unknown event that led to mitral valve repairment was not reported. On 17-FEB-2015, the patient's measles titers were drawn and were low. The patient sought medical attention (saw a physician). The outcome of low measles titer was not reported. The relatedness between the vaccination and the adverse events was not reported. Under internal review the an unknown event that led to mitral valve repairment was considered to be medically significant. Additional information has been requested.
red rash at injection site and swelling of the lymph node, no arm soreness - her PCP prescribed medrol dose pack for the symptoms and recommended she use claritin 12 hour tablets
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 9:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 9:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 45.95.  Concomitant products were not provided.  On 14-Feb-2021, at excursion time 09 AM, temperature was 32, at 10 AM temperature was 32, at 11 AM temperature was 32, at 2 PM temperature was 35 and at 3 PM temperature was 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Heart beating fast, no appetite, light-headed, queasiness. 10/6/2016 8:00 AM: VERY light-headed, dizzy, nauseated, felt like I might faint when standing. This lasted all day into evening. When I awoke next morning, it was all gone.
Client was monitored for 15-20 minutes after injection and then left facility. At approximately 1340, client returned to facility explaining while driving home after vaccine felt like though throat became itchy.  Had client take a seat and took her vitals: 122/70, O2 97%, Pulse 82. No visible redness or swelling in throat, mouth, or face. Client's chest was slightly red but was scratching chest/neck.   Administered Benadryl 25mg at 1400.  Took vitals intermittently throughout this time, all stable.  By 1442, client reported itchiness had subsided in throat. No visible redness to chest.  Client's brother picked her up at 14:50 (did not let client drive d/t drowsiness caused by benadryl).
Tip of her tongue of very red and sore; Painful, nasty blister in the same spot on the tip of her; Tounge redness; Feeling unwell; muscle ache; sore arm; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (was presented inside her mouth on the roof of her mouth and on her tongue. and on side of her face.), general body pain and pain. Previously administered products included Shingles with an associated reaction of herpes zoster (received 7 to 8 years ago). Concurrent medical conditions included post polio syndrome.   On 16th June 2019, the patient received the 1st dose of Shingrix. On 16th June 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and tiredness. On 17th June 2019, the patient experienced feeling unwell and muscle pain. On 19th June 2019, the patient experienced sore tongue, tongue blistering and tongue redness. On an unknown date, the outcome of the pain in arm and tongue blistering were recovering/resolving and the outcome of the feeling unwell, sore tongue and tongue redness were unknown and the outcome of the tiredness was not recovered/not resolved and the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, tiredness, muscle pain, sore tongue, tongue blistering and tongue redness to be related to Shingrix.  Additional details were provided as follows: The patient had shingles shot 7 to 8 years ago from the date of reporting. In November 2018, the patient presented shingles inside her mouth on the roof of her mouth and on her tongue. It also presented on the side of her face.  The patient received vaccine on her right arm and on the same night her arm was sore. The next day the patient's both arms ached and she was not feeling well. The patient was really tired and on Sunday she felt the worse regarding the tiredness. The muscle soreness improved but the right arm still hurts as of the day of reporting. The morning, on the day of reporting, while brushing her teeth, she noticed that the tip of her tongue of very red and sore and a couple of hours ago she noticed a painful, nasty blister in the same spot on the tip of her tongue. The reporter consented to follow up.
(L) arm sore, red, patchy induration. No fever. Pt had allergy shots in same arm the previous day.
sudden onset intense itching and recurrent( increased when compared to initial reaction) redness and swelling. symptoms have continued; not at day 4 despite taking Benadryl cream; took Motrin one day
Mother reports hives on thighs and arms 5 days after receiving Dtap/Hib, Prevnar,Hep B, ProQuad, Hep A.  Mother also reported fever on and off for 2 weeks (highest temp 104), and last week child developed a round, raised, lacy rash on trunk of body. Mom took child to the Clinic for the hives, child was prescribed Benadryl.  Mom spoke to doctor's office, who stated child is OK- to keep child hydrated and give Tylenol for temp.  Mom stated that child is AA&O x3, no seizures, no screaming, behavior OK, tired with fever, resting often.  Asked mom if she had any questions.  Discussed "normal" side effects of live vaccines, reviewed/reminded mom of the MMR and Varicella VIS forms.
Injection site pain; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 28-Jul-2022 Reporter's comment: The nurse reported that the patients received Bexsero and had experienced injection site pain and other symptoms that led her to visit the emergency room. No other details were given. The reporter consented to follow up. Additional Supportive Information: This case had been linked with US2022AMR112709, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR112709:same report, other patient
Fever to 103F, lasting 4 days. Leg pain and swelling. Unable to bear weight for 2 days; 3 more days of limp.
Backache; Sweating; Diarrhea once; Pain in ears; Chills; Thrown up once; Joint Pain; Headache; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), HYPERHIDROSIS (Sweating), DIARRHOEA (Diarrhea once), EAR PAIN (Pain in ears) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced BACK PAIN (Backache), HYPERHIDROSIS (Sweating), DIARRHOEA (Diarrhea once), EAR PAIN (Pain in ears), CHILLS (Chills), VOMITING (Thrown up once), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and FATIGUE (Exhausted). At the time of the report, BACK PAIN (Backache), HYPERHIDROSIS (Sweating), DIARRHOEA (Diarrhea once), EAR PAIN (Pain in ears), CHILLS (Chills), VOMITING (Thrown up once), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.
Extreme arm pain, some minor muscle aches.  Acetaminophen helps.  Also some possible chest pain that began about a week after vaccination.
medication error due to temperature excursion that exceeded the stability data and Tenivac was administered to patient, with no reported adverse event; medication error due to temperature excursion that exceeded the stability data and Tenivac was administered to patient, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 70-year-old (unknown gender) patient, reported a medication error due to temperature excursion that exceeded the stability data and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] was administered to patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Aug-2022, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT strength: standard (formulation, dose , route: unknown) (lot number: U7092AA and expiry date: 24-Jun-2023) in unknown administration site for Immunization and on the same day tenivac was administered to patient, with no reported adverse event (poor quality product administered) and medication error due to temperature excursion that exceeded the stability data, with no reported adverse event (product storage error) (unknown latency).  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable for both events.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pneumonia vcc. given in upper lft arm, following A.M, a welt appeared w/pain, swelling, redness, warmth, slowly spreading. Returned back to clinic, was told to go to urgent care, was given antibiotics.
it's been 5 months, can I take the second now; 2 strokes; Atrial fibrillation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Aug-2021 and was forwarded to Moderna on 29-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (2 strokes) and ATRIAL FIBRILLATION (Atrial fibrillation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced CEREBROVASCULAR ACCIDENT (2 strokes) (seriousness criterion medically significant) and ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it's been 5 months, can I take the second now). At the time of the report, CEREBROVASCULAR ACCIDENT (2 strokes) and ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it's been 5 months, can I take the second now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is also Inappropriate schedule of vaccine  administered in this case.
a couple weeks after dose 2 of vaccine I noticed that I had no strength in my legs, I couldn't walk very far. I went to cardiologist and he sent me to vascular surgeon. The vascular surgeon told me that I am 85 to 95 % blocked in my legs. He suggested surgery but I am afraid to do so. Because I have a friend that had blockage with surgery, now he is helpless in a hospital bed in a nursing home. I believe the blockage in my legs are due to the vaccine because my wife and I had vaccine at the same time and ended up with same problems.
12/17/21 5:00 AM; High temperature, sneezing. Gave Tylenol/Ibuprofen every 4-6hrs a needed to keep fever down.  Called Doctor's office to report illness at 7:30AM.
Chills, fever, headache, nausea, muscle aches, joint pain, HOT RED SPLOTCHES ON SKIN (back, back of neck, under eye).
Made me feel crappy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   The reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received first shot and made him/her feel crappy. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Client tested positive for COVID-19 on 8/15/21 and was hospitalized. He has been inpatient and still is hospitalized as of 8/30. Was informed patient also had pneumonia.
Alternating sweating and cold; Alternating sweating and cold; stomachache; Nausea; Fatigue; Headache; This is a spontaneous report from a non-contactable healthcare professional (reporting for herself). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 10:45 in right arm at single dose for COVID-19 immunization. Medical history included hypothyroidism and major depression from an unknown date and unknown if ongoing. The patient had no allergies to medication, food, or other products. The patient had first dose of BNT162B2 on 18Dec2020 15:00 via intramuscular in left arm at single dose for COVID-19 immunization. Concomitant medications included levothyroxine, bupropion hydrochloride (WELLBUTRIN), "birth control" (not further specified, and escitalopram. 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. On 08Jan2021, the patient experienced alternating sweating and cold, stomachache, nausea, fatigue, and headache at 1:00 AM. She was not hospitalized, and the events were reported as non-serious. Therapeutic measures taken as a result of the headache and included acetaminophen. The outcome of the events was resolving. The patient underwent lab tests and procedures which included nasal swab: negative in Nov2020. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Follow-up (14Jan2021): This is a follow-up report combining information from duplicate reports 2021013335 and 2021015838. The current and all subsequent information will be reported under manufacturer report number 2021015838. Additional information included: reaction data (alternating sweating and cold, stomachache, nausea, fatigue, and headache).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Minor chills started around 7pm.  By 11pm chills were moderate and accompanied by chattering teeth. Symptoms abated by 3am.