chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Headache; Body sore; hot; This is a spontaneous report from a contactable consumer (Patient reported). A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, as a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. It was reported that patient received Pfizer Covid first dose yesterday and experienced chills, headache, body sore, hot, and he still has headache and body sore today. The patient further wanted to know if its ok to drink Theraflu. Patient had already spoke to the safety department but did not have any reference number to provide. The outcome of the events chills, hot was unknown and outcome for headache and body sore was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was vaccinated on Friday, 07/23/21, started feeling extremely tired, sluggish, couldn't stay awake Friday evening and in to Saturday. Fell asleep in a drive thru and at a stop light and ended up going to ER on Sunday where it was confirmed she was having a stroke.
shakes; cough; arm was sore; body aches from head to toe with a severe headache; some diarrhea; sore throat; chills; fatigue; body aches from head to toe with a severe headache; fever of 101.1 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), COUGH (cough), PAIN IN EXTREMITY (arm was sore), PAIN (body aches from head to toe with a severe headache) and DIARRHOEA (some diarrhea) in a female patient of an unknown age 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (shakes), COUGH (cough), PAIN IN EXTREMITY (arm was sore), PAIN (body aches from head to toe with a severe headache), DIARRHOEA (some diarrhea), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), FATIGUE (fatigue), HEADACHE (body aches from head to toe with a severe headache) and PYREXIA (fever of 101.1 degrees F). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 28-Feb-2021, TREMOR (shakes), COUGH (cough), PAIN (body aches from head to toe with a severe headache), DIARRHOEA (some diarrhea), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), FATIGUE (fatigue), HEADACHE (body aches from head to toe with a severe headache) and PYREXIA (fever of 101.1 degrees F) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
Initial report received from a healthcare professional on 16 September 2013. A 52-year-old female patient had received an intramuscular dose of FLUZONE (batch number: UH906AB, expiry date-06/30/2014) in the left deltoid on 13 September 2013. The patient had received numerous previous doses of Influenza vaccine. The patient had no known pre-existing physician diagnosed drug allergies, birth defects, medical history and illness at time of vaccination. Concomitant medications were not reported. Patient did not receive any other concomitant vaccines. On 16 September 2013, the patient had experienced swelling, bruising at vaccination site of left arm, soreness of her ankle and wrist joints. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Follow up information received from a healthcare professional on 21 October 2013. The patient had received 0.5 ml dose of FLUZONE at 14:30 hours. The patient had adverse event at 07:15 hours. The patient had no illness at the time of vaccination. The patient had received CRESTOR 10 mg and Zolpidem 10 mg as concomitant medication. The patient had not received any corrective treatments and no laboratory investigation were done. List of documents held by sender: none.
pt recvd vax;pt devel urticaria;tenderness,inject site;vertigo;dizziness;confus;behavior disturbance;erythema,inject site;flushing;arthritis;myalgia;tachycardia;insomnia;edema;angioneurotic;vaginitis;palpitation;petechiae;asthenia;irritabil
noted swelling of lt upper arm w/reddened welts/hives/hot to touch; c/o pain upper arm; elevated temp (102 orallly, nausea & upset sotmach; 16JUL94 hives;
Symptoms were, dizziness, headaches, slight fever, haziness, I did not know where I was and could not do my daily functions, this went on for about 24-48 hours. I was extremely sleepy and then three times I physically fell, I fell at home once, and I was in the store and someone helped me up and the third time I was in the yard doing yard work. The many people that I talked to including my Dr. and nurse told me I was having a side effect of the vaccine and advised to take Emergency-C, and that helped me a whole lot.
severe headache, body aches, fever (highest 102.3),  and flank pain (right) for 7d. As well as, milder nausea/vomiting. Mild cough after 6d of vaccination (#2).
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 9-week-old patient of unknown gender. On 05-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date 31-JAN-2020). On 17-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Redness at injection site; Pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist reported that the patient received FluLaval Quadrivalent and had redness and pain at the injection site. The reporter consented to follow up. The registered pharmacist had no further details but was agreeable to recontact. This case was linked with the cases US2019AMR165268 and US2019164595, reported by same reporter.
Stomach Cramps; nausea, almost vomiting; freezing; A spontaneous report was received from a female consumer of unknown age, who was also the patient, who received Moderna's COVID-19 vaccine and experienced stomach cramps (abdominal pain upper), freezing (chills), and nausea, almost vomiting (nausea).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was freezing, had nausea, almost vomiting, and stomach cramps. The patient did not have a fever. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.    The outcome for the events stomach cramps, freezing, and nausea, almost vomiting was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of nausea, chills and abdominal pain, a causal relationship cannot be excluded.
Pt came to Nurse Treatment Room c/o pain in left arm since Tdap injection 1 wk. prior. Severe pain from shoulder to fingers, feeling of coldness within arm, reduced ROM in shoulder.
pt recvd vax;exp inject site swelling, erythema & tenderness;sxs still persisting at time of rpt;tx warm compresses;reported to nurse 7Mar sxs still persisting
nose bleed; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) and PAIN IN EXTREMITY (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN for Coagulation disorder NOS, METOPROLOL TARTRATE (METOPROLOL XL) for Hypertension, PANTOPRAZOLE for Stomach discomfort.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Apr-2021, the patient experienced EPISTAXIS (nose bleed). On 25-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, EPISTAXIS (nose bleed) outcome was unknown. Not Provided      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.   No medical history, lab data, and treatment medications are provided
Rebound COViD 19 infection after Paxlovid treatment; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Rebound COViD 19 infection after Paxlovid treatment) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     The patient's past medical history included Unspecified inflammatory polyarthropathy. Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: EN6198) on 25-Feb-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: ER8730 Location of injection: Arm Left) on 25-Mar-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: 30155BA Location of injection: Arm Left) on 07-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy (Name of drug not reported). Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 19-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound COViD 19 infection after Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COViD 19 infection after Paxlovid treatment) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Rebound COViD 19 infection after Paxlovid treatment. Device Date : 29-May-2022. Company comment: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 39 days after administration of fourth dose of mRNA-1273, there was no information provided regarding the initial three doses. Patient underwent treatment regimen of Paxlovid on May 17-21, 2022. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 39 days after administration of fourth dose of mRNA-1273, there was no information provided regarding the initial three doses. Patient underwent treatment regimen of Paxlovid on May 17-21, 2022. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
stiffness in leg/stiffness has spread to the knee and calf; achiness has spread to the knee and calf; achiness in leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achiness in leg), MUSCULOSKELETAL STIFFNESS (stiffness in leg/stiffness has spread to the knee and calf) and MYALGIA (achiness has spread to the knee and calf) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (achiness in leg). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in leg/stiffness has spread to the knee and calf) and MYALGIA (achiness has spread to the knee and calf). At the time of the report, PAIN IN EXTREMITY (achiness in leg), MUSCULOSKELETAL STIFFNESS (stiffness in leg/stiffness has spread to the knee and calf) and MYALGIA (achiness has spread to the knee and calf) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
My symptoms began on the 27th and I had a feeling like my lungs were inflamed. The next day it was a dry cough. I tested negative two days in a row. I tested positive with PCR on the 3rd day. I then had a fever and hacking cough and congestion and this lasted another 2 days. I started PAXLOVID on the 28th. As of March 4th I felt better and tested negative on Tuesday the 7th and tested positive again two days later. With the rebound case I have had horrible congestion and fever came back. I am feeling better as of now.
General malaise like after getting the flu shot,; Arm hurt at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise like after getting the flu shot,) and VACCINATION SITE PAIN (Arm hurt at the site of injection) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (General malaise like after getting the flu shot,) and VACCINATION SITE PAIN (Arm hurt at the site of injection). At the time of the report, MALAISE (General malaise like after getting the flu shot,) and VACCINATION SITE PAIN (Arm hurt at the site of injection) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. no concomitant medications are provided. treatment to the events not reported.
Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2017051212) on 20-Mar-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS VACCINE AND TOXOID (Tetanus Toxoid) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's relevant medical history and concomitant medications were not reported. On an unspecified date following vaccination (Latency unknown), the patient experienced allergy to tetanus vaccines and toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Pt states severe redness, swelling of arm and itching in the arm that the injection was given. Also increased blood pressure that led to a dr office visit.
Papular urticaria - onset of erythematous maculopapules 3/13/06 on neck, chest, face and upper abdomen. No vesicles, no pustules.
New RMA was administering  first COVID vaccine, RMA pressed on plunger before administration to patient ,  About only 0.1mL administered to patient.
extensive redness & itching @ inj site & also neck & chest area;lasting 45-60min in duration
Inadvertently administered pediatric dose of Havrix (HepA).  Error noted during visit.  Adminsitered Adult dose of Havrix per guidance.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions nor allergies. On 18-JAN-2017, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, anatomical location, lot# and expiry date were not reported). On an unknown date in January 2017, the patient experienced headaches and body aches. Unspecified treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient sought medical attention by contacting the pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
4 hours post injection I experienced a significant drop in blood sugar; This is a spontaneous report from a contactable other hcp (reporting for herself).   A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN 5318), via an unspecified route of administration right arm single dose on 27Jan2021 12:00 (at the age of 46) for covid-19 immunisation. No other vaccine was received in four weeks.  Medical history included type 2 diabetes mellitus, rhinitis allergic, myalgia, dairy intolerance. Concomitant medications included metformin, insulin degludec, liraglutide (XULTOPHY), lisinopril, rosuvastatin. The patient experienced (4 hours and 45 min post injection) a significant drop in blood sugar on 27Jan2021 16:45. The patient underwent lab tests and procedures which included blood glucose from 112 (mid-day value) to 73 on 27Jan2021. Patient did not require medical attention and was able to manage the drop with juice. No other issues nor problems occurred related to this change in blood sugar. The outcome was recovered
HEART PALPITATIONS OFF AND ON; FEEL LIKE STUFF MOVING AROUND BODY ESPECIALLY IN LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced heart palpitations off and on, and feel like stuff moving around body especially in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like stuff moving around body especially in legs, and the outcome of heart palpitations off and on was not reported. This report was non-serious.
back pain; CHILLS; TIREDNESS; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), CHILLS (CHILLS) and FATIGUE (TIREDNESS) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced BACK PAIN (back pain), CHILLS (CHILLS) and FATIGUE (TIREDNESS). At the time of the report, BACK PAIN (back pain), CHILLS (CHILLS) and FATIGUE (TIREDNESS) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.