chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had severe body shakes as if subjected to freezing temperatures for approx. 2 hours from 03:00 AM to 05:00AM with body temperature at 98.5 degrees farenheit and shaking stopped at 05:00 and body temperature was 101.7 degrees farenheit. Throughout the day, body temperature ranged from 98.7 degrees farenheit to 101.9 degrees farenheit. There was some slight body aches as well. By 05/09/2021 side effects went away,\.
Laryngomalacia; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGOMALACIA (Laryngomalacia) in a 1-month-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Hypertension, Maternal exposure during pregnancy and Ultrasound abdomen on 23-Oct-2020.    No Medical History information was reported.    On 30-Dec-2020, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 13-Jun-2021. In July 2021, the infant was diagnosed with LARYNGOMALACIA (Laryngomalacia) (seriousness criterion medically significant). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy. The vaginal delivery occurred on 09-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 108472 grams (239lbs 3oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. The fetal weight was 3827 grams with length as 53.34 and head circumference as 34.8. At the time of the report, LARYNGOMALACIA (Laryngomalacia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No Treatment medications was provided by the reporter.  The patient's mother had normal ultrasound on 23-Oct-2020, 15-Jan-2021, 19-Mar-2021 and 13-May-2021. On 20-Mar-2021, the patient glucose for one hour.   The patient's mother gestation period was 39.  Company Comment:   This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   This case was linked to MOD-2021-272273 (Parent-Child Link).   See case MOD-2021-272273 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2021: No specific follow-up information recorded. On 01-Aug-2021: Follow up information was received: The additional reporter (Physician) and pregnancy outcome report added.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
4PM screaming crying-temp 104 w/APAP;520PM talked to MD who recommended DT; 630PM a/screaming stopped-mom used APAP & cold compresses;
pt rcvd vac covid pt stated feeling tingling to lips tongue, throat ems notified continuous vs hyperventilation inability to talk 02 applied @ 4l/nc Epipen admin 02@4l/mask ems arrived
This spontaneous report was received from a physician refers to a multiple patients of unknown age. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 L043214, 30-AUG-2017. Temperature 26 Fahrenheit 5 hours, 52 F 35mins and the vaccine was administered. There was no previous excursion. Additional information has been requested.
A 50 year old female vaccinated at 14:15 on 10/29/01, using reconstituted that morning with preservative-free diluent (vaccine lot 4008284, diluent lot 040601). On 11/15/01 recheck revealed primary response with crusting scab and 3cm surrounding induration. Redness noted in areas in contact with tape and pt was switched to paper tape for dressing changes. On 11/6/01 recheck revealed 3" (about 7.5cm) redness and induration surrounding vaccine site. Fullness of axilla on the same side as vaccine site was noted without palpable node. The pt was empirically begun on Augmentin, 250mg TID and redness and induration noted to be "mostly gone" by the nurse who rechecked pt on 11/9/01. Clinical dx: 'possible secondary infection of vaccine site, vs late reaction to vaccine components'.
Was very weak, dizzy, poor memory.  I felt very extreme health reaction for over 7 days.  It was my error not acknowledging allergic to Sulfa.
4/23 Fainted in the lobby about 5 min after shot. When I came to I was surrounded by paramedics and completely dizzy  with fever and sweaty. Declined to go to hospital ER and went home. Bed for about 36hrs but after kept having severe issues until 4/26. Kept my NP updated but nothing was worsening or ongoing and I recovered from this instance.
headache, severe throat pain/pharyngitis/sinus pain, fatigue, chills, muscle pain. ER admission 2/13.  Persistent severe throat pain and weakness thru today (2/19/21); covid test negative; strep test negative
¨stings¨, in his neck arteries; Pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (¨stings¨, in his neck arteries) and VACCINATION SITE PAIN (Pain in the arm of the injection) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ATORVASTATIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN (¨stings¨, in his neck arteries) and VACCINATION SITE PAIN (Pain in the arm of the injection). The patient was treated with MONTELUKAST ongoing since an unknown date for Pollen allergy, at an unspecified dose and frequency. At the time of the report, PAIN (¨stings¨, in his neck arteries) and VACCINATION SITE PAIN (Pain in the arm of the injection) had resolved.            This case was linked to MOD21-083785 (E2B Linked Report). This case was linked to MOD-2021-095666 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: TCR: Pt AE improved, everything is fine, declined HCP consent.; Sender's Comments:  MOD21-083785:
I get rash my face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (I get rash my face) 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) UNK dosage form. On an unknown date, the patient experienced RASH (I get rash my face). At the time of the report, RASH (I get rash my face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants included.  No treatment included.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non signi folloup
had gotten GBS; This is a spontaneous report from a contactable consumer. This female consumer reported similar events for five patients. This is 5th of five reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had gotten GBS (guillain-barre syndrome) on an unspecified date with outcome of unknown.  In reporter city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019264899 Same reporter/products/events, different patients
Tingling in the side of her mouth; her tongue started tingling; she had dry mouth then it turned into a metallic taste; Her blood pressure was elevated; she had dry mouth then it turned into a metallic taste; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left Arm on 26Jan2021 at 1:04PM as a single dose for COVID-19 immunisation, lot number: EL8982, expiration date: 31May2021. Medical history included penicillin allergy (she was diagnosed as a child) and high blood pressure. Concomitant medication included diltiazem (CARDIZEM) from 2011 and ongoing for high blood pressure. Patient did not receive other vaccine in four weeks prior to the COVID vaccine and did not receive additional vaccines on same date of the COVID vaccine. Patient got the vaccine on 26Jan2021 (yesterday) and after ten minutes of having the vaccine she started getting tingling on the sides of her mouth. Five minutes later she had dry mouth then it turned into a metallic taste. Later her tongue started tingling. They monitored her there for about an hour. Her blood pressure was elevated. Eventually the tingling stated to go down after an hour. They said it was a minor reaction and they were not going to report it. She is kind of freaking out. She knows there have been limited cases of Bell's palsy and sometimes tingling is how it starts. Her tongue started tingling about 30 minutes after the vaccine. Then about two hours it seemed to subside. Last night it started coming back. It started coming back around 09pm, so eight hours after getting the vaccine. The tongue, the sides of her mouth, and lips were tingling. Initially it was on both sides of her mouth that she is tingling. Last night it was more on left side, which is the side the vaccine was given on. When she woke up the morning of the report it was gone. Patient recovered on 27Jan2021 from tingling in the side of her mouth and tingling tongue, while outcome of the other mentioned events was unknown.
I HAD TWO SHINGLE VACCINATION.SOME GOT SHJINGLE TWICE/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 73-year-old 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 2 Shingles vaccination and got shingles. The patient said that some got shingles twice and some did not get 2nd for their lifetime. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR187365, reported by the same reporter.
mom of child reported pt devel diarrhea & vomiting;pt recovered 1-2 days;mom attributed this event to HIBTITER;
Low grade fever, muscle aches, joint pain, headache, fatigue, upset stomach x 36 hours.
Pain; Hotness of left arm; Redness of left arm; Soreness in left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pain), FEELING HOT (Hotness of left arm), ERYTHEMA (Redness of left arm) and PAIN IN EXTREMITY (Soreness in left arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced PAIN (Pain), FEELING HOT (Hotness of left arm), ERYTHEMA (Redness of left arm) and PAIN IN EXTREMITY (Soreness in left arm). At the time of the report, PAIN (Pain), FEELING HOT (Hotness of left arm), ERYTHEMA (Redness of left arm) and PAIN IN EXTREMITY (Soreness in left arm) outcome was unknown.        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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
hard shaking chills; fever of 103.5, nausea, weakness, body aches x 6 hours & residual weakness & queasiness x several days
redness, swelling and pain from the swelling down to her elbow; redness, swelling and pain from the swelling down to her elbow; redness, swelling and pain from the swelling down to her elbow; she was supposed to be given Pneumovax on 12Mar2020 not the Prevnar 13.; she was supposed to be given Pneumovax on 12Mar2020 not the Prevnar 13.; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 70-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) intramuscular on 12Mar2020 at 0.5 ml, single for immunization at the physician's office. Medical history included lung condition from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The nurse reported that they gave a dose of Prevnar 13 to a patient that was previously vaccinated with PREVNAR 13 and she had redness, swelling and pain from the swelling down to her elbow. She says she was given the PREVNAR 13 for the first time on 09Jul2018 and the most recent administration in which the patient experienced the adverse event was 12Mar2020. She says she was supposed to be given PNEUMOVAX on the 12Mar2020 not the PREVNAR 13. The redness pain and swelling started shortly after the injection a resolved shortly after the injection. She confirmed that the redness, pain, and swelling had resolved completely.  Information on the batch number has been requested.
Information has been received from a physician concerning a 20 year old female patient with a history of chlamydia who completed a GARDASIL (lot# unspecified) series on following dates: first dose on 11-DEC-2008, second dose on 09-FEB-2009 and third dose on 28-MAY-2009. There was no concomitant medication. The physician reported that the patient got the positive result for high risk HPV virus on an unknown date after completing GARDASIL series. The patient had sought medical attention (detail unspecified) and no treatment was given for the adverse event. At the time of report, the outcome of the adverse event was unknown. Follow up information has been received from a registered nurse reported that the 20 year old female patient was also with sulfonamide allergy and with no known adverse event following prior vaccination and illness at time of vaccination. The patient received the first dose of GARDASIL (lot# 0947X), second dose (lot# 1423X) and third dose (lot# 0294Y) by intramuscular administration on deltoid. Lab diagnostics studies were performed: on 28-JUN-2011, Papanicolaou test (PAP) with atypical squamous cells of undetermined significance (ASCUS); on 01-JUL-2011, positive HPV culture with high risk subtype; on 28-JUL-2011, colposcopy with biopsies, results were positive for severe dysplasia with endocervical gland involvement. It was reported that LEEP (Loop electrosurgical excision procedure) of the cervix was scheduled for 08-SEP-2011. At the time of report, the outcomes of the adverse events were unknown. ASCUS, positive HPV culture with high risk subtype and positive for severe dysplasia with endocervical gland involvement were considered to be other important medical events by the reporter. Additional information has been requested.
She was completely fine before the vaccine. The morning after, she started having trouble breathing. It attacked her heart, caused inflammation of the heart, until it forced fluid into the lungs (because of the failing heart), making it impossible for her to breathe. She died. We found our loved one on the ground, where she'd been laying in the hot sun for hours, where she'd tried desperately to get air in. She was blue, foaming at the mouth, from the fluid pushed into her lungs. By 1:00pm, less than 12 hours after getting the vaccine, my sister was dead.
Patient reported via phone call to pharmacy. Dizziness and SOA several hours after administration of vaccine. Patient was encouraged to go to the emergency room where she was treated and released. Patient reports being unconscious for several hours of treatment and was told she would not wake up. Patient was released home several hours later and was not admitted to the hospital.
Caller states that the lady who just left her apartment is having the same issues as the caller.; sometimes when they scratch it will bleed.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Caller states that the lady who just left her apartment is having the same issues as the caller."; SKIN HAEMORRHAGE (non-serious), outcome "unknown", described as "sometimes when they scratch it will bleed.".  Additional Information: Number of covid vaccine was not provided. Reason for no lot number of covid vaccine: Caller unwilling to complete the report. Expiry date of covid vaccine was not provided. Caller states that she got the vaccine last February and got the second dose by 03Mar2021. She then got the booster dose in October.  Caller says that she started being itchy from the moment she got the vaccine. States that with the second dose she was itchy. States that the booster dose really set it off and she got a rash. States that a man at her gym and a lady who just left her apartment have the same problem. This report is concerning the lady who just left the caller's apartment. Caller states that she declines to provide further information on the man at her gym and the lady that she knows who have the same issues as her. States that she will ask the lady about it and that lady can call herself. Caller states that the lady is about the age of the caller and the caller states that she gave the lady some of her antihistamines she had left over.  States that it helped a little bit. Caller states that the lady is suffering like the caller. Caller states that sometimes when they scratch it will bleed.  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-202200473977 same product and event, different patient;US-PFIZER INC-202200474055 same product and event, different patient
Still feels like heart racing at times; felt a rush to the head,felt a rush of dizziness,feels like may faint; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt a rush to the head,felt a rush of dizziness,feels like may faint) and PALPITATIONS (Still feels like heart racing at times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026B21A) for COVID-19 immunisation.     Concurrent medical conditions included Caffeine allergy (very sensitive to caffeine and stays away from these because makes heart race) and Drug allergy (very sensitive to Sudafed, take child's dosage in many medications due to sensitivity.).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (felt a rush to the head,felt a rush of dizziness,feels like may faint). On an unknown date, the patient experienced PALPITATIONS (Still feels like heart racing at times). At the time of the report, DIZZINESS (felt a rush to the head,felt a rush of dizziness,feels like may faint) and PALPITATIONS (Still feels like heart racing at times) outcome was unknown.            Age of the patient was reported as over 60 years old.  No concomitant medications were reported. No corrective treatment was provided.  When patient got second dose, felt a rush to the head. The second day after second dose, patient felt a rush of dizziness and feels like may faint. Still feels like heart racing at times.   This case was linked to MOD21-091252 (E2B Linked Report). This case was linked to MOD-2021-139244 (Patient Link).; Sender's Comments:  MOD21-091252:
Patient described pain on arm of injection and redness around area date above is when patient reported reaction but symptoms might had happened before patient described little swelling of lips as well.
Approximately 10-15 minutes following administration of Td, .5 cc IM.  Pt experienced numbness in mouth and around lips. Sent to ER.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2013, the patient received the first dose of GARDASIL injection, intramuscularly (dose, lot #, expiry date and anatomical location were not specified). In September 2013, the patient was vaccinated was vaccinated with the second dose of GARDASIL injection, intramuscularly (dose, lot #, expiry date and anatomical location were not reported). In December 2013, the patient was administered with the third dose of GARDASIL injection, intramuscularly (dose, lot #, expiry date and anatomical location were not provided). The reporter stated that the patient's parents were concerned that GARDASIL obtained from the pharmacy and transported to the physician's office might had been improperly stored. The parents  were concerned about the second and the third dose, as the vaccines were stored in their car. No adverse events were reported. Product quality complaint (PQC) was no involved. Additional information has been requested.
I had fever blur vision the next morning of 02/24/2021 fever, chills and then I passed out, My husband called the paramedics they took my vitals and I was okay. They checked my blood pressure and they left.
I got Shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient he/she got the Shingles vaccine and a week later got shingles. The follow-up would not possible as no contact details were available.