chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19 after vaccination; Fever  101F from COVID-19 disease after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after vaccination) and PYREXIA (Fever  101F from COVID-19 disease after vaccination) in a 25-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (Tested positive for COVID-19 after vaccination) and PYREXIA (Fever  101F from COVID-19 disease after vaccination). At the time of the report, COVID-19 (Tested positive for COVID-19 after vaccination) and PYREXIA (Fever  101F from COVID-19 disease after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 101 (High) Fever of 101F. In December 2021, SARS-CoV-2 test: positive (Positive) Tested Positive.         No Concomitant product use was reported.  The reporter stated that their granddaughter who was the patient had a fever of 101F and tested positive for COVID. The patient was coming over to get together in December. The reporter does not have the patient's vaccination card or information and was not sure if the granddaughter had Moderna COVID-19 vaccine, but the reporter was sure that the patient had 2 doses of the COVID-19 vaccine.  No treatment information was provided. Company comment This case concerns a 25-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19. The event occurred on an unknown day after the administration of the second dose of mRNA-1273 vaccine. The reporter does not have the patient's vaccination card or information and was not sure if the granddaughter had Moderna COVID-19 vaccine, but the reporter was sure that the patient had 2 doses of the COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-426765 (Patient Link).; Sender's Comments: This case concerns a 25-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19. The event occurred on an unknown day after the administration of the second dose of mRNA-1273 vaccine. The reporter does not have the patient's vaccination card or information and was not sure if the granddaughter had Moderna COVID-19 vaccine, but the reporter was sure that the patient had 2 doses of the COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
fever; Chills; more neck pain than normal; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 26-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm Right on 17Mar2021 13:30 (at the age of 26-years-old) as single dose for COVID-19 immunisation. Medical history included polycystic ovaries from 2016 and ongoing Verbatim: Polycystic ovarian syndrome, pyrexia (Her Mom had a hard time with the vaccine, had a fever both times but didn't have the arm thing), anaemia, headache, neck pain, vitamin d deficiency, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. ferritin taken for anaemia, start and stop date were not reported. colecalciferol (D3 VITAMIN) taken for vitamin d deficiency, start and stop date were not reported. loratadine taken for hypersensitivity from Apr2021 to an unspecified stop date; ibuprofen taken for headache, neck pain, start and stop date were not reported. Flu Vaccine a couple of years ago where she felt pretty bad, 2018. As a child she had flu vaccines(2018), but parents were weird and so she did not get as many of them. On 17Mar2021 after the first shot, she noticed more neck pain than normal but it went away quickly, she had fever and chills. Therapeutic measures were taken as a result of more neck pain than normal , fever, chills .Patient received treatment with Tylenol initially the day she had fever and chills, Ibuprofen for Chronic Neck Pain a couple of times. Patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 2 via an unspecified route of administration on 09Apr2021 12:30 at 26 years old (Lot number: EW0153) as single dose on left arm for covid-19 immunisation. The outcome of more neck pain than normal was recovered on an unspecified date in Mar2021 and outcome of fever and chills was unknown.  No follow-up attempts are needed. No further information is expected.
After administering the 4 vaccine (in order as indicated above), patient leaned over and began moving around (right arm flailing) and was initially thought to be resisting vaccination. Patient then appeared to become listless/sleeping. Jerking movements last less than 30 seconds, patient was then alert and appropriately responsive within a few minutes. Patient reported sleepiness and injection site soreness only. Vital signs were taken: HR 83, BP 92/69 RUE, RR 24, O2 sat 99% on RA. Once alert and oriented, patient was given a cool compress for her forehead and cool water. Mother reported that patient had no breakfast, only had a little milk earlier in the morning. Patient was observed for 15 minutes, and remained in the waiting area for another half an hour for observation. After resolution of occurrence, her vaccination series was completed (last vaccine-MMR) with mother's approval. Mother was told to bring child to the ED if she acted unusually or if there were any concerns for her health including recurrence or new symptoms. *Please note language barrier: mother translated.
sore arm for three days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (She got the Pfizer covid vaccine series but the first one,), for COVID-19 IMMUNIZATION. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm for three days".  Additional information: She got the Pfizer covid vaccine series but the first one, she turned her head away because she doesn't like to watch and she didn't feel a thing and no side effects and she is concerned the person may not have given her the first dose. She watched when she got the second dose and she had a sore arm for three days. Her pulmonary doctor said he was in bed with fever and all kinds of stuff for 12 hours after getting the vaccine.  She is concerned she may not have gotten the first one. Should she get a third one. No unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
COVID-19 positive; Lack of drug effect; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19 positive) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine and Morphine) and Blood pressure high.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, the patient experienced COVID-19 (COVID-19 positive) (seriousness criterion hospitalization) and VACCINATION FAILURE (Lack of drug effect). The patient was hospitalized for 10 days due to COVID-19. At the time of the report, COVID-19 (COVID-19 positive) outcome was unknown and VACCINATION FAILURE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2022, SARS-CoV-2 test: Positive.         Patient was on other medication consumption.   Before she got the booster, she got COVID-19.  Reporter believed that the patient received antibiotics as a treatment.  Company Comment:  This is a spontaneous case concerning a 93-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 which required hospitalization for 10 days. The event occurred 1 year and a half after the administration of the second dose of mRNA-1273 vaccine. Vaccination failure is also consider in this case. Treatment recevied was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 93-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 which required hospitalization for 10 days. The event occurred 1 year and a half after the administration of the second dose of mRNA-1273 vaccine. Vaccination failure is also consider in this case. Treatment recevied was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient was 15.5 when he received his first dose of pfzier. No adverse events
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On 24-MAR-2014 the patient was vaccinated with ZOSTAVAX (lot # J013138; expiry date: 17-JAN-2015) one single shot via "injection". On an unspecified date in March 2014 the patient experienced injection site rashes and that were warm and spread across her arms after vaccination. The rash resolved itself on 28-MAR-2014 and the patient was completely recovered. The patient had not sought medical attention. This is one of two reports from the same reporter. Additional information has been requested.
Patient is having extreme abdominal pain, longterm extreme low immune health, excessive sinus & lung congestion, difficulty breathing, extreme lethargy & fatigue, causing loss of work as well as excessive time in bed not her normal behavior.
1MAR96 4PM pt began crying unconsolably & cont until 2MAR96 @ 430PM;pt felt warm to touch (temp not taken); took cat naps through the noc;leg was red, warm, swollen & tender to touch;took APAP
Headache, Myalgia, Diarrhea, Runny nose, swollen left subclavicular node Narrative:
lightheaded feeling; intense itching and crawling feeling; intense itching and crawling feeling; cold, headache developed; Chills; cold, headache developed; odd feeling; Throat got scratchy but did not close; Skin flushed; Allergic reaction; nausea; Joints ache; Cough; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, intramuscular, administered in Arm Left on 14Sep2021 10:30 (Batch/Lot Number: FC3184) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 24Aug2021 10:30 (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included ongoing hypothyroidism and high cholesterol from Nov2005, seasonal and sulfa allergies, pinched nerve on Aug2021, acid reflux from 1993, gastric sleeve from 2014, Gallbladder removal in 2013, Hysterectomy and appendectomy in Nov2005, has allergies to eggs, peanuts, tomatoes, wheat from Mar2019 and ongoing. The patient also had amoxicillin allergy. The patient had no family medical history. Concomitant medication included baclofen taken for pinched nerve, pain from 02Sep2021 and ongoing; omeprazole taken for acid reflux from 2006 and ongoing; citalopram taken for mood depression from 2009 and ongoing; ezetimibe taken for high cholesterol from 2015 and ongoing; amitriptyline taken for mood depression, neuropathy peripheral from 2009 and ongoing; levothyroxine sodium taken for hypothyroidism from 2005 and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergies from an unspecified start date and ongoing; naproxen taken for pinched nerve, pain from 02Sep2021 and ongoing. No other vaccine in four weeks. Within 5 min of getting the injection on 14Sep2021 10:35, he started with a lightheaded feeling, lips started itching which spread to whole body eye, palms, ears, everyplace intense, crazy itching and crawling feeling, cold, headache developed. She felt a chill or odd feeling wash over me a few times. It was 7pm and she still has itching and off/lightheaded feeling. She took 2 Benadryl and 2 Tylenol. She already had Zyrtec and Flonase in her system. She took Zyrtec the night before 25 mg Benedryl before shot, through the day she took 150 mg Benadryl. She also took Tylenol for headache that developed. Throat got scratchy but did not close. Skin on legs, arms, stomach flushed, no hives, had a little nausea (on 10:30), didn't vomit. Joints became achy within a few hours, stayed sore approximately 3 days. The patient has an allergic reaction, received multiple doses of Benadryl itched and coughed for 12 hours. Coughing started within an hour. The outcome of the event cough, chills, joints ache and allergic reaction was recovered while other events was not recovered.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist, concerning a 32 years old patient of an unknown gender. There were no concurrent conditions, medical history or concomitant medications reported. On 26-JAN-2017, the patient was vaccinated with a dose of PROQUAD (dose, frequency and route not reported; lot # and expiration date were unspecified) for prophylaxis, which was outside of the recommendations in the PROQUAD prescribing information. No adverse effect was reported. No product quality complaint was involved (PQC). Additional information has been requested.
I got extreme diarrhea with lots of blood at 5 pm. I had a few more episodes that lasted until about 12am midnight. I got very weak. I was trying everything so I called 911 when I felt like I was going to faint. I also called my sister. The ambulance took me to the hospital and I remained in the emergency room over night. They did a cat scan and found cyst on my liver but no blockage. They were doing HNH to see if I was bleeding internally. They did a lot of lab work and I had an IV for a period of time. I was released Tuesday evening. I was kept for observation. It was recommended that I have a colonoscopy done as I was living or ginger ale and Jello. They would not complete the colonoscopy there. I suspect that this was a hemorrhoid's that burst. I had hemorrhoid's removed previously and they left 2 there. I believe that this was what it was. The diarrhea subsided at the hospital and my urine was clear. I passed a small amount of blood in stool when I was there. I was prescribed Vitamin D, Vitamin B, and Iron. I do hope I have recovered but I don't know.
The pt experienced chicken pox on 1/1/01 through 1/10/01.
vaccine was reconstituted with sterile water; vaccine was reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In February 2022, the patient received Menveo. In February 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-July-2022 Reporter's comment:  The reporter was the pharmacy intern reported that the patient was given an incorrectly reconstituted dose of Menveo in February 2022. The vaccine was reconstituted with sterile water. The reporter consented to follow up via mail. Additional supportive information: Menveo reconstituted with sterile water, instead of the supplied diluents, was administered in error which led to wrong solution used in drug reconstitution error and Inappropriate dose of vaccine administered.
This case was reported by a consumer (subject's father) via a claims benefit company and described the occurrence of fainting in a female subject (a minor) of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 12 September 2012 the subject received a dose of BOOSTRIX (unknown details). On 12 September 2012, within minutes of vaccination with BOOSTRIX, the subject experienced fainting. No additional details were provided. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 11 November 2013 via pharmacist who reported the 12-year-old subject experienced "synergetic effect" in addition to fainting within minutes of receiving BOOSTRIX intramuscularly on 20 August 2013. The pharmacist reported discrepant information regarding the onset dates; previously the onset date of the fainting was 12 September 2012, currently the onset of fainting and "synergetic effect" is 20 August 2013. The fainting and "synergetic effect" resolved on 20 August 2013. The reporting pharmacist did not consider the events serious. The pharmacist did not attribute the events to erroneous administration or suspected transmission of an infectious agent via medicinal product. No action was taken with BOOSTRIX.
Benign Positional Vertigo started during sleep at night and diminishes but still present through the day.  It has lasted 9 days so far. Last time I had BPV was after my first 2 Moderna Covid shots 2/9/21 & 3/19/21 that started 5/20/21 and lasted for a month.  Before that I had BPV about every 2 or 3 years for 3 or 4 days. The duration of condition and being about 2 months after Moderna vaccine is what makes it stand out. I have not reported the 2021 reaction to CDC except here.
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 17-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Covid 19 infection; Covid 19 infection; She was not feeling well; Sore throat; This is a spontaneous report received from a contactable nurse. This nurse reported for a 17-year-old female patient (reporter's granddaughter). A 17-year-old female patient received bnt162b2 (Solution for injection; Batch/lot number and Expiry Date: not provided), dose 1 via an unspecified route of administration on 15Jul2021 (at the age of 17-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not provided. The reporter stated that her granddaughter had her first dose on 15Jul2021, and she was unable to get the second dose of the vaccine, which was schedule on 05Aug2021, because she was not feeling well on an unspecified date in 2021, and so she waited. She tested positive for a mild case of the COVID-19 virus on 10Aug2021, her granddaughter only had a very mild case, they initially thought it was an ear infection as she happened to wear a hearing aide, but she had like a sore throat one day (on an unspecified date in 2021) and would be fine the next day. It sounded like her granddaughter was now doing well, she was feeling well and was back to her normal activities. The patient underwent lab test and procedure which included COVID-19 virus: Positive on 10Aug2021. The outcome of events Covid 19 infection was recovered on an unspecified date in Aug2021 and outcome of events She was not feeling well, and Sore throat was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: As per the information in the case provided, the causal association between the events COVID-19 and Drug Ineffective and the suspect drug bnt162b2 cannot be excluded
Pt complained of flu-like symptoms including low grade fever, chills, aches and pains for several weeks.
bile in her urine; could not sleep for two days; could not eat for two days; sick; weak; tired; This spontaneous case was reported by a consumer and describes the occurrence of BILE OUTPUT ABNORMAL (bile in her urine), SLEEP DEFICIT (could not sleep for two days), DECREASED APPETITE (could not eat for two days), ILLNESS (sick) and ASTHENIA (weak) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced BILE OUTPUT ABNORMAL (bile in her urine), SLEEP DEFICIT (could not sleep for two days), DECREASED APPETITE (could not eat for two days), ILLNESS (sick), ASTHENIA (weak) and FATIGUE (tired). At the time of the report, BILE OUTPUT ABNORMAL (bile in her urine), SLEEP DEFICIT (could not sleep for two days), DECREASED APPETITE (could not eat for two days), ILLNESS (sick), ASTHENIA (weak) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
At injection site,: raised, hot to touch,  hard, getting larger on 3rd day, entire right side hurts, difficulty lifting arm, itchy
two syncopal episodes back to back within 24 hours of second dose of vaccine resulting in displaced fracture of proximal phalanx of right little finger.  this fracture will require two surgeries to repair and loss of work about 12 weeks